FDA Adverse Event
Malfunction
Summary report: N
MAQUET SAS
MDR report key: 2501446
·
Received March 14, 2012
Report
- Report Number
- 9710055-2012-00005
- Event Type
- Malfunction
- Date Received
- March 14, 2012
- Date of Event
- February 14, 2012
- Report Date
- February 17, 2012
- Manufacturer
- MAQUET SAS
- Product Code
- FTD
- PMA / PMN Number
- K932451
- 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
THE MEDICAL STAFF EVALUATED THE DEVICE AND FOUND A VISIBLE CRACK ON THE SPRING ARM WELD SEAM. A LOCAL DEALER REPLACED THE SPRING ARM WITH A NEW ONE, AND VERIFIED THE OTHER SIMILAR UNITS IN THE FACILITY. THIS MALFUNCTION WAS PREVIOUSLY ADDRESSED IN THE U.S. THROUGH A DEVICE CORRECTION: FDA NUMBER Z-0182-188-2010. (B)(4). EXEMPTION # (B)(4). MAQUET MEDICAL SYSTEMS USA SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MANUFACTURING FACILITY. MAQUET (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.
Description of Event or Problem · 1
CUSTOMER REPORTED THAT THE CUPOLA WAS NOT MOVING AS USUAL DURING A SURGERY. THE HOSPITAL DID NOT REPORT INJURIES. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAQUET SAS | FTD | MAQUET SAS | HANAULUX 2000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |