FDA Adverse Event
Malfunction
Summary report: N
HUT EXT DR FINAL ASSY - STANDARD
MDR report key: 2447143
·
Received January 31, 2012
Report
- Report Number
- 1518293-2012-00014
- Event Type
- Malfunction
- Date Received
- January 31, 2012
- Date of Event
- January 12, 2012
- Report Date
- January 31, 2012
- Manufacturer
- LIEBEL-FLARSHEIM CO
- Product Code
- KQS
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FIELD SERVICE ENGINEER (FSE) INVESTIGATED AND FOUND THE GENERATOR CONSOLE WAS FAILING AT POWER UP AND REPLACED THE CONSOLE. FSE VERIFIED PROPER OPERATION PER MFRS SPEC USING SEDECAL GENERATOR SERVICE MANUAL AND HUT SERVICE CHECKLIST. UNIT PASSED CHECKOUT PROCEDURES AND WAS RETURNED TO FULL SERVICE.
Description of Event or Problem · 1
IN (B)(6), CUSTOMER REPORTED VIA PHONE THAT A GENERATOR CONSOLE FAILURE OCCURRED DURING AN UNK PROCEDURE ON A FEMALE PT. PHYSICIAN COMPLETED THE PROCEDURE. NO INJURIES TO REPORT.
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 | UNK |