FDA Adverse Event
Malfunction
Summary report: N
HUT EXT DR FINAL ASSY- REVERSE
MDR report key: 2153446
·
Received June 21, 2011
Report
- Report Number
- 1518293-2011-00109
- Event Type
- Malfunction
- Date Received
- June 21, 2011
- Date of Event
- May 31, 2011
- Report Date
- May 31, 2011
- Manufacturer
- LIEBEL-FLARSHEIM CO.
- Product Code
- KQS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FIELD SERVICE ENGINEER TROUBLESHOT PER SERVICE MANUAL REPORT OF CONSOLE THAT WOULD NOT STAY POWERED UP AND REPLACED THE GENERATOR CONSOLE. FSE THEN VERIFIED PROPER OPERATION USING HUT DR SERVICE MANUAL, SEDECAL GENERATOR SERVICE MANUAL, HUESTIS COLLIMATOR SERVICE MANUAL, AND THE INFIMED PLATINUM ONE TECH MANUAL. SYSTEM RETURNED TO FULL SERVICE BY THE CUSTOMER.
Description of Event or Problem · 1
ON (B)(6): CUSTOMER REPORTS THAT A MALE PATIENT WAS HAVING A UROLOGY PROCEDURE FOR STENT PLACEMENT WHEN THE SYSTEM FAILED TO FLUORO. PHYSICIAN COMPLETED THE PROCEDURE VIA ENDOSCOPY. NO REPORTED INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HUT EXT DR FINAL ASSY- REVERSE | UROLOGY SUITE | KQS | LIEBEL-FLARSHEIM CO. | HUT EXT DR | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |