Device product
Seattle PAP Plus, MP02260
Z-1439-2023
Product summary
- Event
- Event 92049
- Status
- Terminated
- Classification
- Class I
- Quantity
- 32,050 untis
- Official record key
device-enforcement:Z-1439-2023
Official wording
Reason: Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Code information: UDI-DI: 04048675548904; All lots distributed prior to 03/20/2023 (lots other than 0367.2702.13).
Distribution pattern: Domestic: US Nationwide Distribution.
Derived failure modes
-
Unknown
Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.