FDA Adverse Event
Malfunction
Summary report: N
HUT EXT DR FINAL ASSY-REVERSE
MDR report key: 2093549
·
Received April 5, 2011
Report
- Report Number
- 1518293-2011-00066
- Event Type
- Malfunction
- Date Received
- April 5, 2011
- Date of Event
- March 14, 2011
- Report Date
- March 14, 2011
- Manufacturer
- LIEBEL-FLARSHEIM CO.
- Product Code
- KQS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FIELD SERVICE ENGINEER CONFIRMED THE CONTROL ROOM TOWER HAD BEEN MOVED FOR FLOOR REPAIRS AND THEN REPLACED. FSE FOUND THE INFIMED/GIM CONNECTOR DISCONNECTED, CAUSING THE ISSUE. FSE RECONNECTED THE CONNECTOR AND VERIFIED PROPER OPERATION PER (B)(6). FSE COMPLETED HUT SERVICE CHECKLIST AND CUSTOMER RETURNED THE FULLY FUNCTIONAL SYSTEM TO SERVICE.
Description of Event or Problem · 1
ON (B)(6): CUSTOMER REPORTS MALE (UNREPORTED AGE) HAVING A RENAL STENT PLACEMENT WHEN THE ROOM FLUORO FAILED. STAFF MOVED A PORTABLE FLUORO C-ARM INTO THE ROOM AND PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. NO REPORTED INJURY, PATIENT IS FINE.
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 |