FDA Adverse Event
Malfunction
Summary report: N
HUT EXT DR FINAL ASSY-STANDARD
MDR report key: 1053542
·
Received May 28, 2008
Report
- Report Number
- 1518293-2008-00203
- Event Type
- Malfunction
- Date Received
- May 28, 2008
- Date of Event
- March 3, 2008
- Report Date
- March 3, 2008
- Manufacturer
- LIEBEL-FLARSHEIM CO.
- Product Code
- KQS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
LIEBEL FLARSHEIM MFG REPORT: FIELD SERVICE ENGINEER REPLACED GENERATOR INTERFACE MODULE AND VERIFIED OPERATION. UROLOGY SYSTEM RETURNED TO FULL SERVICE BY THE CUSTOMER.
Description of Event or Problem · 1
ON 05/27: CUSTOMER REPORTS THAT DURING THE WEEKEND, WHILE PERFORMING A ROUTINE ROOM CHECK OUT, THEY FOUND THE ROOM WOULD NOT FLUORO OR PERFORM DIGITAL SPOTS, THEY EXPERIENCED NO PROBLEM DURING THE PREVIOUS WEEK PROCEDURES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HUT EXT DR FINAL ASSY-STANDARD | UROLOGY SUITE | KQS | LIEBEL-FLARSHEIM CO. | HUT EXT DR | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |