FDA Adverse Event
Malfunction
Summary report: N
HUT EXT DR FINAL ASSY-REVERSE
MDR report key: 2210404
·
Received August 5, 2011
Report
- Report Number
- 1518293-2011-00144
- Event Type
- Malfunction
- Date Received
- August 5, 2011
- Date of Event
- July 27, 2011
- Report Date
- July 27, 2011
- Manufacturer
- LIEBEL-FLARSHEIM CO.
- Product Code
- KQS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FIELD SERVICE ENGINEER (FSE) TROUBLESHOT REPORT OF NO FLUORO AND FOUND NO FLUORO SIGNAL PRESENT AT THE GENERATOR INTERFACE MODULE (GIM) BOX. FSE REPLACED THE X-RAY FOOTSWITCH ASSEMBLY AND VERIFIED PROPER OPERATION PER (B)(6). UNIT PASSED CHECKOUT PROCEDURES AND WAS RETURNED TO SERVICE.
Description of Event or Problem · 1
ON (B)(6): OPERATING ROOM CHARGE RN REPORTS THAT A MALE WAS HAVING A RETROGRADE PYELOGRAM WHEN THE FLUORO FAILED. PHYSICIAN COMPLETED THE PROCEDURE WITH THE ENDOSCOPE. 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 |