Device product
Breath Tech, Safe Spot Infant Resuscitator, BT2000 Series, Single 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-0174-2013
Product summary
- Event
- Event 63347
- Status
- Terminated
- Classification
- Class I
- Quantity
- 14,602 total for all units
- Official record key
device-enforcement:Z-0174-2013
Official wording
Reason: Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
Code information: Code: Product List 071012, Product Codes: BT2200FK, Lot #100196, BT2216, Lot #100138, BT2216F, Lot #100139, BT2216K, Lot #100197, BT2220, Lot #100140, BT2220, Lot #100141, BT2416, Lot #100142, BT2416F, Lot #100143, BT2416K, Lot #100198, BT2420, Lot #100144, BT2420F, Lot #100145 and BT2420FK, Lot #101081.
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.