FDA Adverse Event
Malfunction
Summary report: N
HUT EXT DR FINAL ASSY-REVERSE
MDR report key: 6118957
·
Received November 21, 2016
Report
- Report Number
- 1518293-2016-00088
- Event Type
- Malfunction
- Date Received
- November 21, 2016
- Date of Event
- October 20, 2016
- Report Date
- November 21, 2016
- Manufacturer
- LIEBEL-FLARSHEIM
- Product Code
- IXR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- RADIOLOGIC TECHNOLOGIST
Narratives
Description of Event or Problem · 1
MECHANICAL FAILURE; WILL NOT FLURO. UNAWARE OF ANY INJURIES TO PATIENT OR STAFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 767150 | HUT EXT DR FINAL ASSY-REVERSE | HUT EXT DR FINAL ASSY-REVERSE | IXR | LIEBEL-FLARSHEIM | 404007 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |