FDA Adverse Event
Other
Summary report: N
9710055-2009-00002
MDR report key: 1343020
·
Received March 2, 2009
Report
- Report Number
- 9710055-2009-00002
- Event Type
- Other
- Date Received
- March 2, 2009
- Product Code
- FSY
- PMA / PMN Number
- K070442
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
THIS INCIDENT IS THE FIRST REPORTED CASE FOR A BROKEN HANDLE HOLDER. ROOT CAUSE HAS YET TO BE IDENTIFIED. MAQUET FOREIGN COUNTRY BELIEVES THAT THE INCIDENT COULD HAVE BEEN PREVENTED IF THE CUSTOMER FOLLOWED PROPER HANDLING INSTRUCTIONS AS STATED IN THE USER MANUAL. PER THE USER MANUAL, UNDER BASIC MAINTENANCE, DAILY CHECKS: THE OPERATOR NEEDS TO CHECK THE LIGHTHEADS FOR CHIPPED PAINT, IMPACT MARKS AND ANY OTHER DAMAGE. MAQUET INC. SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MFG FACILITY. MAQUET FOREIGN COUNTRY 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 |