FDA Adverse Event
Malfunction
Summary report: N
POWERLED
MDR report key: 4093138
·
Received August 21, 2014
Report
- Report Number
- 9710055-2014-00063
- Event Type
- Malfunction
- Date Received
- August 21, 2014
- Date of Event
- July 25, 2014
- Report Date
- July 25, 2014
- Manufacturer
- MAQUET S.A.S.
- Product Code
- FSY
- PMA / PMN Number
- K070442
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
A MAQUET FIELD SERVICE TECH INSPECTED THE DEVICE, REPAIRED IT AND RETURNED THE UNIT TO SERVICE. THIS INVESTIGATION IS ON-GOING AND THE RESULTS WILL BE INCLUDED IN A FOLLOW-UP REPORT. MAQUET MED SYSTEMS USA SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MFG FACILITY. MAQUET (B)(4) 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 DURING AN OPERATION, A METAL COVER FELL OFF FROM THE SPRING ARM OF THE SURGICAL LIGHT. THERE WAS NO PATIENT INVOLVEMENT, NOR INJURIES REPORTED TO MAQUET. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 506882 | POWERLED | FSY | MAQUET S.A.S. | PWD500DF V HD K3 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |