FDA Adverse Event
Malfunction
Summary report: N
HUT EXT DR FINAL ASSY-STANDARD
MDR report key: 2093913
·
Received April 19, 2011
Report
- Report Number
- 1518293-2011-00078
- Event Type
- Malfunction
- Date Received
- April 19, 2011
- Date of Event
- March 25, 2011
- Report Date
- March 25, 2011
- Manufacturer
- LIEBEL-FLARSHEIM CO.
- Product Code
- KQS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PENDING INVESTIGATION. UPON RECEIPT OF INVESTIGATION, A MEDWATCH 3500A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
ON (B)(6): CUSTOMER REPORTS THEY WERE ATTEMPTING TO PERFORM A PROCEDURE WHEN THE ROOM FLUORO FAILED. PROCEDURE WAS CANCELLED AND PT RESCHEDULED FOR ANOTHER DAY. CUSTOMER DID NOT PROVIDE PT OR PROCEDURE INFO, OTHER THAN TO SAY NO PT INJURY, JUST DELAY OF PROCEDURE.
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 |