FDA Adverse Event
Malfunction
Summary report: N
HANAULUX
MDR report key: 1003987
·
Received February 1, 2008
Report
- Report Number
- 3004147784-2008-00001
- Event Type
- Malfunction
- Date Received
- February 1, 2008
- Date of Event
- December 21, 2007
- Report Date
- January 2, 2008
- Manufacturer
- MAQUET S.A.
- Product Code
- FSY
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- TX, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Description of Event or Problem · 1
A SURGICAL LIGHT FELL FROM ITS CEILING SUSPENSION TUBE AFTER A SURGERY CASE. THE NURSE IN THE AREA WAS REPORTEDLY HIT ON THE FOOT, BUT NO INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HANAULUX | FSY | FSY | MAQUET S.A. | LONDON 4201 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |