Device product
Safe Spot Infant Resuscitator, SS3200 Series, Single Patient Use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. 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-0170-2013
Product summary
- Event
- Event 63347
- Status
- Terminated
- Classification
- Class I
- Quantity
- 14,602 total for all units
- Official record key
device-enforcement:Z-0170-2013
Official wording
Reason: Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
Code information: Product List 071012, Product Codes: SS3200MB, Lot #10030, 100251, 100381, 100432, 100656, 100791, 101101, 10131; SS3200MB-2, Lot #100131; SS3200MB-1, Lot #101238, 101370, 101480, 101820, 102009; SS3200MB-MMC, Lot #100129; SS3200MBP-2, Lot #102057; SS3200MBP-M00, Lot #100132, 101462, 102051; SS3200OB, Lot #100133, 100252, 100979, 101178, 101863, 101975 and SS3200OB-PW, Lot #100134, 100253.
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.