FDA Adverse Event
Malfunction
Summary report: N
XTEN
MDR report key: 3905231
·
Received May 28, 2014
Report
- Report Number
- 9710055-2014-00034
- Event Type
- Malfunction
- Date Received
- May 28, 2014
- Date of Event
- April 22, 2014
- Report Date
- April 28, 2014
- Manufacturer
- MAQUET SAS
- Product Code
- FSY
- PMA / PMN Number
- K040735
- Removal / Correction Number
- Z-0182-188-2010
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
THIS MALFUNCTION WAS PREVIOUSLY ADDRESSED IN THE US. THE LIGHT HAS BEEN REMOVED FROM THE SVC PENDING REPAIR.
Description of Event or Problem · 1
THE HOSP REPORTED THAT DURING A SURGICAL OPERATION, THE MEDICAL STAFF HEARD AN ABNORMAL NOISE FROM THE SPRING ARM WHEN POSITIONING THE LIGHT HEAD. AFTER THE OPERATION, THE HOSP ENGINEER FOUND A LARGE CRACK AT THE JOINT BETWEEN THE LIGHT HEAD AND SPRING ARM. NO INJURIES WERE REPORTED. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 314839 | XTEN | FSY | MAQUET SAS | XTENDUODFV | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |