The PB 980 series ventilator is used for pediatric and adult patients who require respiratory support in hospital environments, such as intensive care units and neonatal intensive care units, as well as patient transfers.

Medtronic acquired the ventilator series when it acquired Covidien for US$42.9 billion in 2014. In 2015, Medtronic initiated a recall of more than 650 units because the amount of air delivered to patients may be lower than the planned amount. In 2018, the recall was to initiate software updates and solve user interface issues.

The 2018 software update was released after Australia suspended equipment supply for more than a year. The Therapeutic Goods Administration under the Australian Department of Health has suspended the supply of these devices after multiple reports of screen blackouts, unresponsive user interfaces, and unexpected shutdowns or restarts.

The regulator stated in a September 2017 statement: “This action was taken because the TGA is concerned that until it is corrected, the use of these breathing opportunities increases the potential risk of death, serious injury or illness.” Initial suspension It was six months; however, after reviewing the product, a six-month suspension was applied.

TGA finally lifted the suspension in November 2018 and listed a list of conditions that Medtronic must comply with, including updating the wording of warnings and instructions in the user manual.

After the most recent recall, Covidien asked doctors to immediately stop using these machines and isolate the affected equipment. According to the FDA database entry, if the device has been distributed to others, the manufacturer also requires the customer to notify the facility or personnel of the recall. 

Medtronic said it received multiple reports of equipment malfunctions, which led to investigations and then the company recalled.

The company said in an email statement: “After we investigated six customer reports, we initiated this voluntary medical equipment correction. The report stated that a total of four ventilators were inoperable during use.” “On-site corrective measures. The device contained in may be affected by manufacturing assembly errors, that is, incorrect assembly of capacitors in the ventilator."

The statement stated that possible assembly errors affected equipment manufactured between January 2017 and May 2018, and none of the equipment currently sold has been affected.

The company stated in a statement: “As of Friday, November 12, 2021, all ventilators in the U.S. market within the scope of this on-site corrective action have been inspected, and no equipment has been found to have reverse capacitor problems.” The inspection of the remaining units outside the United States included in the on-site rectification action is nearly complete. As of December 9, 2021, the inspection of the remaining units has been 94% complete."

Although the FDA's database entry indicated that 278 units were affected, Medtronic stated that a total of 284 units were part of the recall.

This article has been updated to include Medtronic's statement.

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Even after the transaction has surpassed last year's figures, analysts predict, especially the active activities of diagnostic companies, especially among diagnostic companies that are cash-rich in COVID-19 test sales in 2020.

"It's really like we were operating in the 1950s," a consultant said of the process. The US Food and Drug Administration has held two meetings in the past year to consider improvements.

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Even after the transaction has surpassed last year's figures, analysts predict, especially the active activities of diagnostic companies, especially among diagnostic companies that are cash-rich in COVID-19 test sales in 2020.

"It's really like we were operating in the 1950s," a consultant said of the process. The US Food and Drug Administration has held two meetings in the past year to consider improvements.

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