Puritan Bennett (ventilators)

2020

Recall of defective ventilators that suddenly turn off

In early December 2021, Medtronic recalls hundreds of defective ventilators that suddenly turned off. This failure is due to an error in the assembly of devices, when the capacitor in the devices was incorrectly assembled, which could lead to a shutdown of the devices in mid-use.

Medtronic recalls hundreds of defective ventilators that suddenly shut down

In 2015, Medtronic paid $43 billion for a merger with Covidien, the company inherited the headquarters of its Irish partner in Dublin and a wide range of medical devices and, accordingly, all related security problems. Throughout this time, the most problematic of the purchased devices was the Puritan Bennett 980 series. Since joining Medtronic, these ventilators have caused Class I recalls, the last of which was initiated by the company in November 2021 and received the most critical assessment from the Food and Drug Administration (FDA). According to the FDA notification, a total of 278 ventilators, which have been distributed around the world, fall under the recall. The FDA did not specify the number of complaints the agency received in connection with the manufacturing error, nor did it note whether any injuries or deaths were associated with it.

Medtronic sent an urgent letter to all affected customers to correct defects in medical equipment, starting November 4, 2021. Employees of the company's technical service began to contact customers to schedule a time to repair ventilators included in the recall. Until the repair is completed, medical institutions are advised to immediately stop using Puritan Bennett 980 ventilators. The devices must be quarantined, according to a warning from Medtronic, and all doctors who may be in contact with the devices must be notified of a manufacturing defect to prevent their further use.^[1]

Launch of the system for remote control of ventilators

In mid-April 2020, US hospitals began introducing a new Medtronic system for remote control of ventilators. It allows you to significantly reduce the number of contacts of medical staff with patients with COVID-19. The corresponding function appeared after the software update of the Medtronic Puritan Bennett line.

As a rule, ventilators require careful control and adjustment of settings depending on the patient's condition, so the medical staff is forced to enter the ward quite often. Hospitals turned to Medtronic to solve this problem, and after 10 days the developers presented the first version of the system for remote control of ventilators.

Hospitals implement Medtronic system for remote control of ventilators

We found a solution unusually quickly, "said Vafa Jamali, senior vice president of Medtronic.

The launch of the remote control system of IVL replaces 65 visits to the ward of one patient with COVID-19, who is on IVL for two weeks. In general, taking into account the workload of regional hospitals, doctors and nurses have to enter the wards of such patients 450 times less often within 2 weeks, that is, the number of contacts is reduced by almost 50%.

Now we use less PPE [personal protective equipment], which is sorely lacking, as everyone is well aware. The new system saves our staff from the need to visit infected wards, and will also certainly have a beneficial effect on the patients themselves, because now we can monitor the condition of ventilators from anywhere in the hospital and make the necessary changes very quickly, "said Kelly Sullivan, head of respiratory care.

In total, the pilot project includes five hospitals in various regions of the United States. The software update is for Medtronic Puritan Bennett 980 (PB980) fans. In the future, the company is ready to deploy the new system for free to all clinics with the necessary equipment.^[2]

Medtronic revealed the specifications of its popular ventilator

At the end of March 2020, Medtronic published in the public domain the technical characteristics of its popular Puritan Bennett 560 (PB 560) ventilator so that anyone can produce it in the face of a global shortage of devices.

The shortage of devices has become so acute that doctors have to choose which of the patients with severe cases of coronavirus infection COVID-19 to prescribe treatment, as if in wartime. Medtronic uses its production lines around the clock to increase the production of ventilators by 40%, but demand still exceeds supply.

Puritan Bennett 560 Ventilator (PB 560)

President Donald Trump has taken the extraordinary step of invoking the Korean War-era Defense Production Act. The American leader called on General Motors and Ventec Life Systems to join the production of medical devices. In addition, even do-it-yourself university researchers have joined the production.

Medtronic sells a ventilator called the PB 560, introduced in 2010, in 35 countries around the world. The company positions it as a reliable critical care tool that can be used by all manufacturers, inventors, startups and academic institutions seeking to accelerate the development and production of ventilators. The company has released the PB 560 usage and maintenance manuals, design requirements documents, manufacturing documents and diagrams to the public at Medtronic.com/openventilator. Medtronic reports that it intends to also post program code and other information.

Over the past few weeks, we have significantly increased the production of Puritan Bennett 980 ventilators. But we also understand that we can do more, "Executive Vice President and President of the Medtronic Minimally Invasive Therapy Group Bob White (Bob White) announced in a press release. - By openly providing manufacturers with data on the design of PB 560, we hope to increase the global production of ventilators to combat COVID-19.[3]

Doubling production

In March 2020, several manufacturers of medical equipment in the United States announced the increase in artificial lung ventilation devices to combat the COVID-19 coronavirus. So, in response to reports of a shortage of such devices, Medtronic announced that it was going to double the production and supply of ventilators.

Puritan Bennett 980 ventilator

Hospitals across America lack protective masks and ventilators. President Donald Trump has called for production to increase needed supplies, citing the Emergency Defense Production Act. Medtronic responded by doubling the number of shifts at a plant in Galway, Ireland. This plant operates around the clock, with additional staff transferred from other Medtronic sites. The company said it prioritizes high-risk areas with a high need for ventilators and is monitoring the situation as it deploys.

Medtronic produces ventilators for patients with acute respiratory failure hospitalized in the hospital and for patients with a subacute condition who receive treatment outside the hospital. By March 2020, the range of this equipment includes the Puritan Bennett 980 and Puritan Bennett 840 models.

Medtronic admits that the demand for ventilators in this situation is much higher than the supply, "explained Bob White, executive vice president and president of the Medtronic minimally invasive treatment group. - No company will be able to meet the current needs of global health systems. Nevertheless, all medical companies are increasing production and establishing partnerships with governments, hospitals and global medical organizations. Medtronic is also committed to supplying as many ventilators as possible to help doctors and patients facing COVID-19.[4]

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