FDA Adverse Event
Other
Summary report: N
*
MDR report key: 1230704
·
Received August 8, 2008
Report
- Report Number
- 9710055-2008-00008
- Event Type
- Other
- Date Received
- August 8, 2008
- Manufacturer
- *
- Product Code
- FSY
- PMA / PMN Number
- k040735
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
ONE MAQUET REP VISITED THE HOSP, FOUND THAT THE WELD SEAM AT THE LOWER END OF THE SPRING ARM WAS BROKEN AND REPLACED IT WITH A NEW ONE. THIS IS THE ONLY REPORTED INCIDENT OF A FAILED WELD ON THIS SPRING ARM. IN NOV 2006, THE THICKNESS OF THE WELDED TUBE WAS INCREASED FROM 1.35 MM TO 2.35 MM. THIS SPRING ARM WHICH HAD THE WELDING BROKEN WAS MADE IN 2004, PRIOR TO THE MODIFICATION. MAQUET 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 |