FDA Adverse Event
Malfunction
Summary report: N
MAQUET SAS
MDR report key: 2995171
·
Received February 27, 2013
Report
- Report Number
- 9710055-2013-00007
- Event Type
- Malfunction
- Date Received
- February 27, 2013
- Date of Event
- January 30, 2013
- Report Date
- February 1, 2013
- Manufacturer
- MAQUET SAS
- Product Code
- FSY
- PMA / PMN Number
- K040735
- Removal / Correction Number
- Z-0182/188-2010
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A MAINTENANCE TECHNICIAN AUTHORIZED BY MAQUET, VISITED THE HOSPITAL AND FOUND THAT THE FRONT PIVOT OF THE SPRING ARM WAS BROKEN. HE REPLACED THE SPRING ARM WITH A NEW ONE. HE INSPECTED SIMILAR DEVICES AT THIS FACILITY AND VERIFIED THERE WERE NO ADDITIONAL ARMS DAMAGED. THIS MALFUNCTION WAS PREVIOUSLY ADDRESSED IN THE U.S. THROUGH THE DEVICE CORRECTION. (B)(4). MAQUET SAS PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.
Description of Event or Problem · 1
THE CUSTOMER REPORTED TO MAQUET THAT PRIOR TO A SURGICAL INTERVENTION, THE SPRING ARM BROKE. THE CUPOLA WAS HELD TO THE SPRING ARM BY ITS CABLE. NO INJURIES WERE REPORTED. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 84127 | MAQUET SAS | FSY | MAQUET SAS | XTEN DF DUO V MS | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |