FDA Adverse Event
Malfunction
Summary report: N
HUT EXT DR FINAL ASSY-REVERSE
MDR report key: 2240876
·
Received August 16, 2011
Report
- Report Number
- 1518293-2011-00147
- Event Type
- Malfunction
- Date Received
- August 16, 2011
- Date of Event
- July 22, 2011
- Report Date
- July 22, 2011
- Manufacturer
- LIEBEL-FLARSHEIM CO.
- Product Code
- KQS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FIELD SERVICE ENGINEER TROUBLESHOT AND ISOLATED THE PROBLEM TO THE SEDECAL CONSOLE. FSE REPLACED THE CONSOLE ACCORDING TO SEDECAL SERVICE MANUAL, VERIFIED PROPER OPERATION ACCORDING TO SERVE CHECKLIST QSSRWI4.1 AND RETURNED THE UNIT TO SERVICE.
Description of Event or Problem · 1
GENERATOR CONSOLE BLANK. ON (B)(6): CUSTOMER REPORTED INCIDENT OCCUR AT THE BEGINNING OF DAY PRIOR TO PT PROCEDURES. THE FACILITY DOES NOT HAVE BACK-UP CAPABILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HUT EXT DR FINAL ASSY-REVERSE | UROLOGY SYSTEM | KQS | LIEBEL-FLARSHEIM CO. | HUT EXT DR | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |