FDA Adverse Event
Other
Summary report: N
9710055-2008-00016
MDR report key: 1258408
·
Received October 17, 2008
Report
- Report Number
- 9710055-2008-00016
- Event Type
- Other
- Date Received
- October 17, 2008
- Product Code
- FSY
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
A MAQUET REP VISITED THE HOSPITAL AND EVALUATED THE DEVICE. HE FOUND THAT PAINT WAS DAMAGED IN MANY LOCATIONS OF THE SURGICAL LIGHT SYSTEM AND CONCLUDED THAT THE DAMAGE IS CONSISTENT WITH LAMP COLLISIONS. A RECOMMENDATION WAS MADE TO THE HOSPITAL TO REPLACE DAMAGED PARTS. 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 |