FDA Adverse Event
Malfunction
Summary report: N
MAQUET SAS
MDR report key: 3243117
·
Received July 17, 2013
Report
- Report Number
- 9710055-2013-00028
- Event Type
- Malfunction
- Date Received
- July 17, 2013
- Manufacturer
- MAQUET SAS
- Product Code
- FSY
- PMA / PMN Number
- K070442
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
A MAQUET FIELD REPRESENTATIVE INSPECTED THE DEVICE. HE REPLACED THE CEILING SUSPENSION WITH A NEW ONE, AND VERIFIED THAT NO FURTHER FRICTION IS OCCURRING. HE VERIFIED THE SIMILAR MAQUET DEVICES IN THE FACILITY AND FOUND NO OTHER MALFUNCTION. THIS INVESTIGATION IS ON-GOING AND THE RESULTS WILL BE INCLUDED IN A FOLLOW UP REPORT. (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
PLEASE REFER IMPORTER REPORT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 332718 | MAQUET SAS | FSY | MAQUET SAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |