FDA Adverse Event
Other
Summary report: N
*
MDR report key: 979514
·
Received July 24, 2007
Report
- Report Number
- 8010652-2007-00003
- Event Type
- Other
- Date Received
- July 24, 2007
- Manufacturer
- MAQUET GMBH AND CO. KG
- Product Code
- FQO
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
BATTERY INDICATOR BOARD WAS EXPOSED TO FLUID USED DURING PROCEDURE. IT WAS NOTED THE ADHESIVE BATTERY INDICATOR LABEL WAS WORN AND THE ADHESIVE SEAL FOUND INEFFECTIVE TO ALLOW INGRESS OF LIQUID. THE SHORT CIRCUIT CONDITION WAS LIKELY DUE TO A LARGE AMOUNT OF LIQUID ENTERING THE TABLE BASE AND CIRCUITRY. THE ADHESIVE BATTERY INDICATOR LABEL SHOULD HAVE BEEN INSPECTED AND REPLACED DURING RECOMMENDED MAINTENANCE PERIOD BEFORE BECOMING WORN AND LOOSENING ITS SEAL. REPAIRS WERE COMPLETED. THE OR TABLE HAS BEEN RETURNED TO CUSTOMER USE. GETINGE USA, INC. SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MFG FACILITY. MAQUET GMBH & CO. KG PROVIDES PROD FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION OF THE DEVICE DESCRIBED IN THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | * | FQO | MAQUET GMBH AND CO. KG | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |