FDA Adverse Event
Malfunction
Summary report: N
HUT EXT DR FINAL ASSY-REVERSE
MDR report key: 3102443
·
Received May 1, 2013
Report
- Report Number
- 1518293-2013-00097
- Event Type
- Malfunction
- Date Received
- May 1, 2013
- Date of Event
- April 15, 2013
- Report Date
- May 1, 2013
- Manufacturer
- LIEBEL-FLARSHEIM CO.
- Product Code
- IXR
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TECH SUPPORT ADVISED CUSTOMER TO CHECK THE CONNECTIONS ON THE GENERATOR INTERFACE MODULE. CUSTOMER REPORTED THAT HE FOUND THE POWER CORD WAS LOOSE, REATTACHED IT AND TESTED THE SYSTEM. THE SYSTEM TESTED GOOD AND IS NOW WORKING NORMALLY.
Description of Event or Problem · 1
ON (B)(6): CUSTOMER REPORTS VIA PHONE THAT DURING AN UNDETERMINED UROLOGY PROCEDURE, THE SYSTEM KEPT LOSING FLUORO. CUSTOMER REPORTS THEY HAD TO REBOOT THE SYSTEM MULTIPLE TIMES TO BE ABLE TO COMPLETE THE PROCEDURE, BUT IT WAS FINALLY COMPLETED. NO INJURY REPORTED. CUSTOMER WOULD NOT PROVIDE PT INFORMATION OR PROCEDURAL INFORMATION, OTHER THAN TO STATE THE PT IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 190435 | HUT EXT DR FINAL ASSY-REVERSE | IXR | LIEBEL-FLARSHEIM CO. | HUT EXT DR | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |