Recall Z-1298-2014 ยท CBK Ventilator, Continuous, Facility Use
Draeger Medical Systems, Inc.
Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500), Evita V500 and /or Babylog VN500 Ventilators, used for ventilation during short term transport of patients within a hospital.
| Date | Mar 28, 2014 (initiated Feb 7, 2014) |
| Status | Terminated |
| Reason | The battery capacity of the optional PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500) did not last as long as expected. |
| Root cause | Component design/selection |
| Action | Drager sent an Urgent Medical Device Recall letter dated February 2014. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to use an affected device for patient transport only if absolutely necessary; not to rely on the battery charge status indicator, always supervise the patient and the ventilator during transport; ensure that they have a manual breathing bag available for manual ventilation as recommended in the instructions for use. If the power fail alarm occurs during transport, immediately provide manual ventilation a |
| Quantity | 1544 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |