FDA Adverse Event
Malfunction
Summary report: N
MAQUET SAS
MDR report key: 2995160
·
Received February 14, 2013
Report
- Report Number
- 9710055-2013-00004
- Event Type
- Malfunction
- Date Received
- February 14, 2013
- Date of Event
- January 9, 2013
- Report Date
- January 9, 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
- HU
- Reporter Occupation
- NOT APPLICABLE
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. 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
DURING AN OPERATION, THE TEAM HEARD A STRANGE NOISE FROM THE ARM OF THE SURGICAL LIGHT, AND SOMEONE MOVED THIS LIGHT ASIDE. DURING THE MOVEMENT, THE LIGHT HAS FALLEN TO THE GROUND. THE CUSTOMER DID NOT REPORT ANY INJURIES. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 64502 | MAQUET SAS | FSY | MAQUET SAS | XTEN DF DUO V | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |