FDA Adverse Event
Malfunction
Summary report: N
XTEN
MDR report key: 4019903
·
Received July 11, 2014
Report
- Report Number
- 9710055-2014-00055
- Event Type
- Malfunction
- Date Received
- July 11, 2014
- Report Date
- June 11, 2014
- Manufacturer
- MAQUET S.A.S
- Product Code
- FSY
- PMA / PMN Number
- K040735
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
HOSP STAFF SENT PHOTOS OF THE CHIPPED PAINT AS WELL AS THE CLEANING PROCEDURE USED, BUT THE PRECISE DEVICE SERIAL NUMBER WAS NOT PROVIDED. ONE OF THE CLEANING AGENTS DESCRIBED IN THE HOSP PROCEDURE CONTAINS PHENOL, WHICH IS IDENTIFIED IN THE DEVICE'S USER MANUAL AS A PROHIBITED CLEANING SUBSTANCE. MAQUET MEDICAL SYSTEMS USA SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MFG FACILITY. MAQUET (B)(4) PROVIDES FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.
Description of Event or Problem · 1
CUSTOMER REPORTED THAT THEIR SURGICAL LIGHT WAS STARTING TO EXPERIENCE FLAKING PAINT CHIPS. NO PATIENT INVOLVEMENT WAS REPORTED BY THE CUSTOMER. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 407839 | XTEN | FSY | MAQUET S.A.S | XTEN | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |