The FDA issued an replace on the June 2021 recall of Philips Respironics ventilators, BiPAP and CPAP gadgets, reporting that there have been a further 7,000+ medical machine experiences (MDRs) and 111 deaths reported for the interval of July 1, 2023 by means of September 30, 2023.
In accordance with the January thirty first FDA replace, since April 2021, the FDA has obtained greater than 116,000 MDRs, together with 561 experiences of dying, reportedly related to the PE-PUR foam breakdown or suspected foam breakdown.
Reviews to the FDA:
| Dates | MDRs Obtained | Reviews of Deaths in MDRs |
|---|---|---|
| April 1, 2021 – April 30, 2022 | >21,000 | 130* |
| Might 1, 2022 – July 31, 2022 | >48,000 | 57* |
| August 1, 2022 – October 31, 2022 | >21,000 | 106* |
| November 1, 2022 – December 31, 2022 | >8,000 | 81* |
| January 1, 2023 – March 31, 2023 | >6,000 | 44* |
| April 1, 2023 – June 30, 2023 | >4,000 | 32 |
| July 1, 2023 – September 30, 2023 | >7,000 | 111 |
The unique recall of those Philips gadgets was introduced by the corporate in June 2021.
On January 26, 2024, Philips Respironics introduced that it might finish the sale of sure ventilators, BiPAP and CPAP gadgets (and extra merchandise), together with some affected by the June 2021 recall and subsequent recollects.
Supply: FDA
