06-28-2024, 09:16 AM
RE: Philips Discontinues Numerous Devices and Halts Dreamstation Sales in the U.S.
FDA
Continuous Ventilator Correction: Philips Respironics, Inc. Updates Use Instructions for BiPAP V30, BiPAP A30, BiPAP A40 Due to Interruptions and Loss of Therapy
This recall involves updating instructions for using BiPAP V30, BiPAP A30, and BiPAP A40 devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions.
Affected Product
Product Names: BiPAP V30, BiPAP A30, BiPAP A40
Unique Device Identifier (UDI)/Model:
00606959049635/BiPAP V30 Auto
00606959039308/BiPAP A30
00606959039476/BiPAP A40
Reason for Updates to Use Instructions
Philips Respironics, Inc. is updating the use instructions for V30, A30, and A40 ventilators due to a failure in the Ventilator Inoperative alarm, which can cause therapy interruption or loss.
The device may:
Reboot intermittently for 5-10 seconds (stopping therapy, blank screen, single audible alert), then restart with the same patient settings.
Reboot intermittently for 5-10 seconds (stopping therapy, blank screen, single audible alert), then restart with factory default settings.
Enter a Ventilator Inoperative state (therapy stopped, audible and visual alarms present) after three reboots within 24 hours, or without a preceding reboot.
These issues can result in therapy interruption or loss, potentially leading to hypoventilation, hypoxemia, hypercarbia, respiratory failure, or death in vulnerable patients.
There have been 952 reported injuries. There have been 65 reports of death.
Continuous Ventilator Correction: Philips Respironics, Inc. Updates Use Instructions for BiPAP V30, BiPAP A30, BiPAP A40 Due to Interruptions and/or Loss of Therapy | FDA
Continuous Ventilator Correction: Philips Respironics, Inc. Updates Use Instructions for BiPAP V30, BiPAP A30, BiPAP A40 Due to Interruptions and Loss of Therapy
This recall involves updating instructions for using BiPAP V30, BiPAP A30, and BiPAP A40 devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions.
Affected Product
Product Names: BiPAP V30, BiPAP A30, BiPAP A40
Unique Device Identifier (UDI)/Model:
00606959049635/BiPAP V30 Auto
00606959039308/BiPAP A30
00606959039476/BiPAP A40
Reason for Updates to Use Instructions
Philips Respironics, Inc. is updating the use instructions for V30, A30, and A40 ventilators due to a failure in the Ventilator Inoperative alarm, which can cause therapy interruption or loss.
The device may:
Reboot intermittently for 5-10 seconds (stopping therapy, blank screen, single audible alert), then restart with the same patient settings.
Reboot intermittently for 5-10 seconds (stopping therapy, blank screen, single audible alert), then restart with factory default settings.
Enter a Ventilator Inoperative state (therapy stopped, audible and visual alarms present) after three reboots within 24 hours, or without a preceding reboot.
These issues can result in therapy interruption or loss, potentially leading to hypoventilation, hypoxemia, hypercarbia, respiratory failure, or death in vulnerable patients.
There have been 952 reported injuries. There have been 65 reports of death.
Continuous Ventilator Correction: Philips Respironics, Inc. Updates Use Instructions for BiPAP V30, BiPAP A30, BiPAP A40 Due to Interruptions and/or Loss of Therapy | FDA
