Device product
VORTRAN Automatic Resuscitator, VARPlus with Extension Kit; Model PCE-5012; Qty: 10 each. Anesthesiology: This device is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure cycled ventilatory support.
Z-2092-2017
Product summary
- Event
- Event 77072
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14 cases (10 each)
- Official record key
device-enforcement:Z-2092-2017
Official wording
Reason: Vortran received a customer complaint that the spin-nut-DSS connector was assembled in the reverse direction on the oxygen tubing; making the connector unable to be screwed on due to the wrong thread direction.
Code information: Model PCE 5012; Lot number/ expiry date: 1419 PCE , 2019-03-12; 1434 PCE, 2019-06-04.
Distribution pattern: CA, MS, FL
Derived failure modes
-
Unknown
Vortran received a customer complaint that the spin-nut-DSS connector was assembled in the reverse direction on the oxygen tubing; making the connector unable to be screwed on due to the wrong thread direction.