FDA Adverse Event
Malfunction
Summary report: N
POWERLED
MDR report key: 3962718
·
Received June 11, 2014
Report
- Report Number
- 9710055-2014-00042
- Event Type
- Malfunction
- Date Received
- June 11, 2014
- Date of Event
- May 14, 2014
- Report Date
- May 14, 2014
- Manufacturer
- MAQUET S.A.S
- Product Code
- FSY
- PMA / PMN Number
- K070442
- Removal / Correction Number
- Z-1730-2014
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
MAQUET HAS NOTIFIED THE F.D.A OF ITS INTENT TO IMPLEMENT A DEVICE CORRECTION TO RESOLVE THIS ISSUE IN THE US THE AMBIENT LIGHT MODULE WAS REPLACED WITH ONE OF A DIFFERENT MATERIAL AND DESIGN. THE DEVICE WAS RETURNED TO SERVICE. 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
THE CUSTOMER REPORTED TO MAQUET THAT AN AMBIENT LIGHT MODULE BROKE DURING A CLEANING PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 344426 | POWERLED | FSY | MAQUET S.A.S | PWD70DFVK3 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |