Device product
Model 731 EMV+ Uni-Vent, Impact Instrumentation Inc., 27 Fairfield Place, West Caldwell NJ 07006. Indicated for use in the management of acute or chronic respiratory failure or during resuscitation by providing continuous positive -pressure ventilation.
Z-2152-2012
Product summary
- Event
- Event 62535
- Status
- Terminated
- Classification
- Class III
- Quantity
- Ten Units
- Official record key
device-enforcement:Z-2152-2012
Official wording
Reason: Ten units of Model EMV+ Devices were shipped out in error before the verification and validation was completed for a new integrated circuit (IC) on the CPU PCB.
Code information: Serial numbers: VCDB120315, VCDB120316, VCDB120299, VCDB120300, VCDB120313, VCDB120307, VCDB120312, VCDB120303, VCDB120310, VCDB120297.
Distribution pattern: US Distribution to the state of Illinois.
Derived failure modes
-
Unknown
Ten units of Model EMV+ Devices were shipped out in error before the verification and validation was completed for a new integrated circuit (IC) on the CPU PCB.