FDA Adverse Event
Malfunction
Summary report: N
HUT EXT DR FINAL ASSY-STANDARD
MDR report key: 1360481
·
Received March 25, 2009
Report
- Report Number
- 1518293-2009-00078
- Event Type
- Malfunction
- Date Received
- March 25, 2009
- Date of Event
- March 6, 2009
- Report Date
- March 6, 2009
- Manufacturer
- LIEBEL-FLARSHEIM CO.
- Product Code
- KQS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
FIELD SERVICE ENGINEER TROUBLESHOT GENERATOR COMMUNICATION ERROR PER GENERATOR SERVICE MANUAL. FSE REPLACED INCOMING LINE 50V FUSES IN THE GENERATOR AND RESEATED GENERATOR INTERFACE CABLE J1 ON THE INTERFACE PCB. THE SYSTEM WAS CHECKED AND VERIFIED FOR PROPER OPERATION PER THE GENERATOR SERVICE MANUAL 7102273. RETURNED TO FULL SERVICE BY THE CUSTOMER.
Description of Event or Problem · 1
ON 03/11: CUSTOMER REPORTS FLUORO FAILURE DURING A PROCEDURE. NO ADDITIONAL INFORMATION MADE AVAILABLE BY THE CUSTOMER. NO REPORTED INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HUT EXT DR FINAL ASSY-STANDARD | UROLOGY SUITE | KQS | LIEBEL-FLARSHEIM CO. | HUT EXT DR | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |