FDA Adverse Event
Malfunction
Summary report: N
HUT EXT DR FINAL ASSY-REVERSE
MDR report key: 1427563
·
Received March 31, 2009
Report
- Report Number
- 1518293-2009-00079
- Event Type
- Malfunction
- Date Received
- March 31, 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
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CLINICAL ENGINEERING REPORTS TO PRODUCT MONITORING, DURING THE PROCEDURE, THE ANESTHESIOLOGIST ACCIDENTLY HIT THE TABLE POWER SWITCH AND TURNED OFF THE TABLE, THEN QUICKLY TURNED IT BACK ON. CLINICAL ENGINEER REBOOTED THE COMPLETE SYSTEM, TABLE AND COMPUTER. CUSTOMER REPORTS, UPON REBOOT, THE ROOM HAS FUNCTIONED NORMALLY EVER SINCE.
Description of Event or Problem · 1
CUSTOMER REPORTS FLUORO WAS LOST DURING A PROCEDURE, BUT STAFF COULD NOT RECALL THE TYPE OF PROCEDURE OR PATIENT INFORMATION. PATIENT PROCEDURE WAS COMPLETED. NO REPORTED INJURY.
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 |