FDA Adverse Event
Malfunction
Summary report: N
HUT EXT DR FINAL ASSY-REVERSE
MDR report key: 2093534
·
Received April 5, 2011
Report
- Report Number
- 1518293-2011-00070
- 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
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FIELD SERVICE ENGINEER CONFIRMED TABLE WOULD NOT LOWER WITH HANDSWITCH OR THE FOOTSWITCH. FSE TROUBLESHOT AND CORRECTED PROBLEM WITH A TABLE HEIGHT PARAMETERS CALIBRATION. WHEN COMPLETED, THE SYSTEM TESTED GOOD IN ACCORDANCE WITH SYSTEM INSTALL AND SERVICE MANUAL. FSE CHECK FOR PROPER OPERATION PER SERVICE CHECKLIST AND CUSTOMER RETURNED THE SYSTEM TO FULL SERVICE.
Description of Event or Problem · 1
ON (B)(6): CUSTOMER REPORTS DURING STENT PLACEMENT PROCEDURE (PATIENT GENDER AND AGE NOT PROVIDED), WHEN THEY TRIED TO LOWER THE TABLE, IT WOULD NOT LOWER. PHYSICIAN HAD TO COMPLETE THE STENT PLACEMENT PROCEDURE STANDING ON A STEP STOOL. 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 |