Device product
Adult Resuscitator, Pro-5000 Series, Single Patient Use, The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
Z-0171-2013
Product summary
- Event
- Event 63347
- Status
- Terminated
- Classification
- Class I
- Quantity
- 14,602 total for all units
- Official record key
device-enforcement:Z-0171-2013
Official wording
Reason: Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
Code information: Product List 071012, Product Code: PRO-5009P, Lot #102217.
Distribution pattern: Nationwide Distribution including IL, OH, NY and TN.
Derived failure modes
-
Unknown
Possible volume leakage through the inlet valve during compressions of the resuscitator bag.