FDA Adverse Event
Other
Summary report: N
9710055-2007-00024
MDR report key: 978287
·
Received November 9, 2007
Report
- Report Number
- 9710055-2007-00024
- Event Type
- Other
- Date Received
- November 9, 2007
- Product Code
- FSY
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER REPORTED THAT THE SCREW OF THE HANDLE SUPPORT BECAME LOOSE GRADUALLY AND FINALLY DROPPED. BASED ON THAT INFO, THE CUSTOMER COULD HAVE DETECTED THIS DEVELOPING CONDITION PRIOR TO IT OCCURRING, USING THE RECOMMENDED MAINTENANCE SCHEDULES. THE MAINTENANCE SCHEDULE REQUESTS TO VERIFY GOOD TIGHTNESS OF ALL VISIBLE SCREWS, PERIODICALLY. THE SUBSIDIARY TECHNICAL STAFF REPAIRED THE DEVICE, AND IT WAS RESTORED TO GOOD CONDITION. GETINGE USA, INC. SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MFG FACILITY. MAQUET S.A. PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FSY |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |