The allegations come as doctors in two hospitals in Mumbai have refused to use AgVa ventilators.

NEW DELHI — Two former employees at controversial medical startup AgVa Healthcare told HuffPost India that the company manipulated the software running its low-cost ventilators to make the devices show they were pumping more oxygen into patients’ lungs than they actually were.

These startling revelations come after doctors at Mumbai’s prestigious JJ Hospital observed a variance between the actual performance of AgVa ventilators, and the performance registered on the device display. The AgVa ventilators were evaluated after JJ Hospital received 39 AgVa devices as a charitable donation. St. George Hospital, which is attached to JJ Hospital and is a dedicated Covid hospital, had received 42 AgVa ventilators.

The JJ Hospital report, written by a panel of five experienced doctors and reviewed by HuffPost India, said, “Maximum level of displayed FiO2 did not indicate actual delivered FiO2 as patient showed signs of desaturation upto 86% on multipara monitor.” 

FiO2, or Fraction of Inspired Oxygen, refers to the percentage of oxygen in the air pumped into a patient’s lung — ranging from 21% (the percentage of oxygen naturally occurring in the atmosphere) to 100%, when pure oxygen is pumped into a patient’s lungs. 

FiO2 is a crucial parameter for COVID patients. “When the lining of the lung gets diseased, patients need higher amounts of oxygen to ensure the body is able to extract enough oxygen,” said Dr Dileep Raman, an ICU specialist. “This happens in pneumonia, ARDS as well as in the case of COVID-19,” he explained.

The JJ Hospital report also echoes several concerns raised by a panel of experienced doctors in Ram Manohar Lohia Hospital in Delhi, who evaluated the AgVa ventilators at the direction of the Modi government’s health ministry. The JJ Hospital and RML Hospital reports flagged similar shortcomings: the AgVa ventilators evaluated were prone to failure, those that worked struggled to maintain critical parameters, the ventilators struggled to deliver high FiO2 percentages, and could not cater to the needs of critically ill patients in ICUs. 

One AgVa ventilator, the JJ Hospital report noted, failed within five minutes of being plugged into a testing machine. Patients connected to the ventilators, the report said, “were getting restless, tachypneic, and were sweating.” Tachypnea refers to a state of rapid, abnormal, breathing.

Workers of AVGA healthcare make portable ventilators at Sector 7 during the lockdown to curb the spread...
Workers of AVGA healthcare make portable ventilators at Sector 7 during the lockdown to curb the spread of coronavirus on April 16, 2020 in Noida.

Last month HuffPost Indiareported that the RML Hospital panel initially rejected AgVa’s ventilators. The ministry then sent the ventilators for re-evaluation to a different panel of doctors who passed the ventilators with the caveat that AgVa’s ventilators were not substitutes for high-end, ICU-grade ventilators and should only be used in cases where a backup ventilator is available. As HuffPost India’s report noted, doctors from Gujarat, Haryana, Uttar Pradesh, Delhi and now Mumbai have raised concerns about the quality and performance of AgVa’s ventilators.

AgVa Healthcare has been in the limelight since March this year when the Modi government ordered 10,000 of the company’s Covid-model ventilators as part of India’s response to the novel coronavirus pandemic. The Modi government has responded to public criticism of its decision to buy AgVa products by insisting that the ventilators are suitable for treating Covid patients. The ventilators are now synonymous with Prime Minister Modi: the devices are being shipped bearing the logo of the Prime Minister’s opaque and unaudited PMCARES Fund, and are a vital part of the government’s PR campaign to deflect criticism that Modi did not do enough to prepare the country for the ongoing pandemic. 

Now, the JJ Hospital report — first reported by the Mumbai Mirror— and the previously unreported accounts of two former employees revive concerns that AgVa Healthcare has overstated the capabilities of their low cost devices.

AgVa Healthcare has rejected claims by its former employees that the company manipulated its software to exaggerate the performance of its devices. 

“This is a completely malafide and false comment. FiO2 can easily be checked on any ventilator by connecting an oxygen analyser to 1% accuracy. Any AgVa ventilator can be tested at any point of time by anyone,” AgVa founder Diwakar Vaish said in an email to HuffPost India. “Also, irrespective of what the ventilator shows, patients will not achieve 100% oxygen saturation if 100% FiO2 is required by the patient and can be checked on the patient monitor.”

The ventilators at JJ Hospital, Vaish said, were not installed by AgVa engineers and were a different, older, model from the ventilators. 

“The ventilators were purchased by donors and distributed to these hospitals and initial installation done by some 3rd party without informing us,” Vaish said. “As our ventilator requires a proprietary breathing circuit and training, the doctors who used it initially did not operate it properly and this resulted in improper ventilation.” 

AgVa is now providing its newest models to JJ Hospital, Vaish said, which were the same models being sold to the Indian government.

FiO2 Issues

One of the former AgVa employees who spoke to HuffPost India said that he noticed the problem in February this year. It was late evening and he was in a hurry as five AgVa Advanced ventilators were going through their final checks before being shipped to a client.

“I was testing the devices and I noticed that the FiO2 is not even reaching 90%,” said the executive, who is no longer working at AgVa, and said he alerted a member of the technical team. 

“He fixed FiO2 in five devices in just 10 minutes with simple lines of code,” the former employee  said, seeking anonymity as he feared reprisals by the company. “FiO2 level is a hardware issue. How can you adjust it via computer? Then he said it’s not adjusted. It’s the same as before—just that the value is changed to show 95 , 97 , 99 or 100.”

“The computer coder puts a command in the ventilator that it will show 99-100% FIO2 reached even if it is 80%,” the former employee  said. “I came to know about this computer code manipulation in February only after it was done in front of me by mistake.”

Ashwani Kumar, a former AgVa sales executive, told HuffPost India that he had seen AgVa ventilators display they were hitting 80% FiO2 (80% oxygen) even when the devices were not connected to an oxygen source. He said he pointed out that the natural percentage of oxygen in air is only 21%, and asked how the ventilator showed it was delivering 80% oxygen without a separate source of oxygen.

“The data displayed by the ventilator is manipulated,” Kumar said. “It has been coded in a way to manipulate the FiO2 value.”

As noted earlier in the piece, Vaish from AgVa has rejected these accounts as “false” and completely “malafide”.

Both former employees also said that AgVa employees were often sent out to perform tasks that they were not formally trained for, such as ventilator installation and troubleshooting, a charge AgVa refutes. 

The report by  JJ Hospital’s doctors offers an example:. When the doctors first flagged problems with their AgVa ventilators, the company sent an employee named Surya Pratap to fix the problem. 

“On 26 May 2020, these various issues including setting of FiO2 were discussed with Mr. Surya Pratap who did software upgradation in wards on AgVa ventilators which means that the ventilators were delivered for patient use without quality control assurance test which could be fatal to patients,” the JJ Hospital report says.

Vaish said, “We routinely upgrade the user interface software to the latest version during the installation. It is part of the SOP of the installation process.”

It is worth noting that the problems flagged by the doctors at JJ Hospital — ventilator failure, FiO2 delivery, desaturation of patients — are not typically user interface problems.

On LinkedIn, Surya Pratap describes himself as a “Digital Marketing Strategist” and a Marketing Specialist at AgVa Healthcare — a job he has held for one year and four months. His prior work experience involves three years in the BPO industry, and little to suggest he is qualified to troubleshoot critical bio-medical devices in a situation where lives are at stake.

In an email, Vaish from AgVa said “Surya Pratap is heading the service team of AgVa and has more than 100 service engineers under him across the country.”

Vaish sidestepped a question on how Pratap was qualified to lead a team of engineers.

“Surya Pratap joined us as a marketing specialist but soon became adept at serving and excelled in his job. Further, he has made his way to the top with his exceptional learning skills over the past months,” Vaish said. AgVa has over 500 employees, Vaish said, “more than” 100 of whom are service engineers.

A senior doctor who was part of the health ministry’s first clinical evaluation trial of AgVa’s Covid ventilators in May this year said the committee called for more validation as they felt the device had been rushed to market.

“We told them, don’t play with the lives of patients. Modify the machine, perfect the machine, don’t hurry it. That was our reason for calling for more validation,” the doctor said. “We should not compromise on ventilator quality. My Indian brothers and sisters should not be harmed by a product we have cleared. Which is why we said the ventilator needs more validation.”

As HuffPost India has previously reported, the government then sent the AgVa ventilator to a different panel of doctors, who cleared it with the caveats that the AgVa Covid model ventilator “should not be considered as a replacement for high-end ventilators in tertiary care ICUs” and that “there should be a provision for backup ventilator in the facility where these ventilators are used.”

JJ Hospital Responds

On June 30, Diwarkar Vaish flew to Mumbai’s JJ Hospital and demonstrated AgVa’s newest Covid model to the hospital’s sceptical doctors. This is the same model that AgVa is supplying 10,000 devices to the Indian government. A doctor present at the demonstration noted that the ventilators carried the PMCARES logo.

“Patients were absolutely comfortable on AgVa ventilator and maintained all vitals (including set Fio2 of 100%). We have our report of the same, signed and accepted by the dean office (copy attached),” Vaish said in an email to HuffPost India. “The doctors agreed that AgVa ventilator is working properly on COVID patients and delivering the desired FiO2 up to 100% easily. THIS CAN BE VERIFIED BY THE SAME DOCTORS AND THE DEAN HIMSELF.”

Yet, the “report” Vaish attached with the mail was a hand-written note in which he claims that doctors at JJ Hospital are satisfied; and the acceptance by the dean’s office, that Vaish referred to, was a rubber-stamp indicating it has been received by “Steno to the Dean” of JJ Hospital.

Ranjit Mankeshkar, the Dean of JJ Hospital, disputed Vaish’s account. Mankeshkar said the hospital would take a decision on AgVa’s latest batch of ventilators only after testing and evaluating the performance of the devices.

“The hospital’s “technical committee has not yet submitted the report,” Mankeshkar said, adding that a demonstration is not the same as actual testing. “So I have nothing new to comment at the moment,” he said.

Nonetheless, Vaish amplified his false claim on Twitter and in a misleading press release on his company website.

Four different doctors who had used AgVa’s ventilators noted that each time they flagged concerns with the device, Vaish claimed that problem lay with doctors who did not know how to use his ventilator.

“It is ridiculous that doctors with decades of experience, who have used 100s of ventilators are having their credibility questioned by a three year old company,” said a doctor from a prominent nation hospital. “We are government employees, so we cannot speak openly, but the public should think about this.

https://www.huffingtonpost.in/entry/pmcares-ventilator-maker-agva-fudged-software-to-hide-poor-performance-ex-employees-say

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