FDA Adverse Event
Malfunction
Summary report: N
HANAULUX 3000
MDR report key: 4180570
·
Received October 15, 2014
Report
- Report Number
- 9710055-2014-00087
- Event Type
- Malfunction
- Date Received
- October 15, 2014
- Date of Event
- September 18, 2014
- Report Date
- September 19, 2014
- Manufacturer
- MAQUET S.A.S
- Product Code
- FSY
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE HANAULUX 3000 SERIES LIGHT SYSTEM IS NOT MARKETED IN THE US. THIS REPORT HAS BEEN MADE DUE TO A SIMILARITY WITH DEVICES MARKETED BY MAQUET IN THE US. THIS MALFUNCTION WAS PREVIOUSLY ADDRESSED IN THE US THROUGH THE DEVICE CORRECTION Z-0182/188-2010. A MAQUET FIELD SERVICE TECHNICIAN INSPECTED THE DEVICE AND FOUND THAT THE FRONT PIVOT OF THE SPRING ARM BROKE AT THE WELD SEAM. THE BROKEN SPRING ARM WAS REPLACED WITH A NEW ONE AND THE DEVICE RETURNED TO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT A SPRING ARM BROKE AND THE CUPOLA DROPPED ONTO THE OPERATING TABLE AFTER A SURGERY. THERE WAS NO PT PRESENT IN THE ROOM WHEN THE EVENT OCCURRED. NO INJURIES WERE REPORTED. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 654574 | HANAULUX 3000 | NA | FSY | MAQUET S.A.S | H4H5DFV | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |