Device product
Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet in length. Oxygen therapy delivery system for adult patient.
Z-0621-2013
Product summary
- Event
- Event 63794
- Status
- Terminated
- Classification
- Class I
- Quantity
- 200 units total, 26 units US
- Official record key
device-enforcement:Z-0621-2013
Official wording
Reason: FPH has become aware that one batch of tubes supplied to FPH may contain hole damage. These tubes were incorporated by FPH into certain 900MR068 reusable circuits with lot numbers 110810 and 111020. If this hole damage is not detected during the standard leak test before patient use, it could potentially result in a gas leak in the breathing system, which may lead to a loss of pressure for the int
Code information: Lots 110810 and 111020
Distribution pattern: Worldwide Distribution - USA including IL, IN, AR and GA.
Derived failure modes
-
Unknown
FPH has become aware that one batch of tubes supplied to FPH may contain hole damage. These tubes were incorporated by FPH into certain 900MR068 reusable circuits with lot numbers 110810 and 111020. If this hole damage is not detected during the standard leak test before patient use, it could potentially result in a gas leak in the breathing system, which may lead to a loss of pressure for the int