FDA Adverse Event
Malfunction
Summary report: N
HUT EXT DR FINAL ASSY-REVERSE
MDR report key: 3130123
·
Received May 21, 2013
Report
- Report Number
- 1518293-2013-00121
- Event Type
- Malfunction
- Date Received
- May 21, 2013
- Date of Event
- May 16, 2013
- Report Date
- May 21, 2013
- Manufacturer
- LIEBEL-FLARSHEIM CO.
- Product Code
- IXR
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TECH SUPPORT TROUBLESHOT WITH BIOMED WHO SAID THE OPERATORS WERE COMPLAINING OF A 'GENERATOR NOT COMMUNICATING MESSAGE' ON THE SEDECAL INTEGRATED CONSOLE AND DISCOVERED THAT THE MAIN GENERATOR WAS NOT TURNED ON. THIS WAS CAUSING THE MESSAGE TO APPEAR. AFTER CYCLING THE 480VAC CIRCUIT BREAKER, THE CONSOLE CAME UP WITHOUT ISSUE AND THE BIOMED SAID THAT THE SYSTEM WAS CURRENTLY FUNCTIONING WITHOUT ISSUE.
Description of Event or Problem · 1
ON (B)(6) 2013 CUSTOMER REPORTS THAT DURING AN UNK UROLOGY PROCEDURE ON AN UNK PT THE FLUORO FAILED. THE PROCEDURE WAS COMPLETED BY MOVING THE PT TO ANOTHER ROOM. NO REPORTED INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 225270 | HUT EXT DR FINAL ASSY-REVERSE | IXR | LIEBEL-FLARSHEIM CO. | HUT EXT DR | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |