FDA Adverse Event
Malfunction
Summary report: N
HUT EXT DR FINAL ASSY-STANDARD
MDR report key: 2480352
·
Received February 28, 2012
Report
- Report Number
- 1518293-2012-00042
- Event Type
- Malfunction
- Date Received
- February 28, 2012
- Date of Event
- February 15, 2012
- Report Date
- February 28, 2012
- Manufacturer
- LIEBEL-FLARSHEIM CO.
- Product Code
- KQS
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FIELD SERVICE ENGINEER (FSE) FOUND THE TUBE WARM UP AND SPOT WORKING BUT NO FLUORO. TROUBLESHOT SYSTEM FINDING A DAMAGED WIRE AT THE FLUORO FOOTSWITCH CONNECTOR. FSE REPAIRED DAMAGED WIRE AT CONNECTOR AND CHECKED UNIT FOR PROPER OPERATION PER HUT SERVICE CHECKLIST. UNIT FULLY FUNCTIONAL. UNIT PASSED CHECKOUT PROCEDURES AND WAS RETURNED TO FULL SERVICE BY THE CUSTOMER.
Description of Event or Problem · 1
(B)(6): CUSTOMER REPORTS VIA PHONE THAT AN APPROXIMATELY (B)(6) FEMALE PATIENT WAS HAVING A URETHROSCOPY PROCEDURE WHEN TE SYSTEM FLUORO FAILED. STAFF MOVED A PORTABLE C-ARM FLUORO UNIT INTO THE ROOM AND THE PHYSICIAN COMPLETED THE PROCEDURE WITHOUT FURTHER INCIDENT. NO REPORTED INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HUT EXT DR FINAL ASSY-STANDARD | KQS | LIEBEL-FLARSHEIM CO. | HUT EXT DR | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR |