FDA Adverse Event
Malfunction
Summary report: N
HANAULUX 2000
MDR report key: 3853588
·
Received April 3, 2014
Report
- Report Number
- 9710055-2014-00020
- Event Type
- Malfunction
- Date Received
- April 3, 2014
- Date of Event
- March 5, 2014
- Report Date
- March 7, 2014
- Manufacturer
- MAQUET SAS
- Product Code
- FTD
- PMA / PMN Number
- K932451
- Removal / Correction Number
- Z-0182/188-2010
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A FIELD SERVICE TECHNICIAN TRAINED BY MAQUET EVALUATED THE DEVICE AND FOUND A CRACKED WELD SEAM AT THE FRONT PIVOT OF THE SPRING ARM. THE SPRING ARM WAS REPLACED WITH A NEW ONE AND THE DEVICE RETURNED TO SERVICE. THIS MALFUNCTION WAS PREVIOUSLY ADDRESS IN THE U.S THROUGH THE DEVICE CORRECTION. (B)(4) SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MANUFACTURING FACILITY. MAQUET SAS 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 THE DEVICE WAS OPERATING DIFFERENTLY THAN EXPECTED AND WAS WORRIED THAT THE LUMINARE COULD FALL WHILE BEING MANIPULATED DURING A SURGERY IN O.R. #1. NO INJURIES WERE REPORTED TO MAQUET. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 202997 | HANAULUX 2000 | FTD | MAQUET SAS | HLX2005 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |