FDA Adverse Event
Summary report: N
*
MDR report key: 1182223
·
Received July 15, 2008
Report
- Report Number
- 3003135857-2008-00044
- Date Received
- July 15, 2008
- Manufacturer
- FLIGHT MEDICAL LTD.
- Product Code
- CBK
- PMA / PMN Number
- k992133
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
IT WAS CONFIRMED THAT THE LAST TIME THIS UNIT WAS SERVICED WAS IN DECEMBER, 2004 AND THE HOUR METER WAS READING 1613. NOT THE HOUR METER READING IS 20612. ACCORDING TO THE MFR'S SVC REQUIREMENTS OF THE HT50 MODEL, THE MOTOR PUMP SHOULD BE REPLACED EVERY 10,000 HOURS. THE DISTRIBUTOR/IMPORTER INFORMED THAT THE PREVENTIVE MAINTENANCE HAS NEVER BEEN PERFORMED ON THIS UNIT AT THE USER FACILITY. DEVICE FAILURE WAS MOST LIKELY RELATED TO USER MAINTENANCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | * | CBK | FLIGHT MEDICAL LTD. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |