FDA Adverse Event
Malfunction
Summary report: N
HUT EXT DR FINAL ASSY-REVERSE
MDR report key: 1051260
·
Received May 22, 2008
Report
- Report Number
- 1518293-2008-00183
- Event Type
- Malfunction
- Date Received
- May 22, 2008
- Date of Event
- April 24, 2008
- Report Date
- April 24, 2008
- Manufacturer
- LIEBEL-FLARSHEIM CO
- Product Code
- KQS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
LIEBEL FLARSHEIM MFG INVESTIGATION REPORT PENDING. ONCE MFG INVESTIGATION REPORT IS RECEIVED, A MEDWATCH SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
CUSTOMER REPORTS THAT FEMALE UNDERGOING A BLADDER RESECTION FOR TUMOR. PT MOVED ONTO THE UROLOGY TABLE, ANESTHESIA WAS INTRODUCED AND PT INTUBATED. PT DRAPED FOR PROCEDURE WHEN THE ROOM LOCKED UP AND WENT DOWN. UNABLE TO REBOOT SYSTEM AND PT HAD TO BE MOVED TO ANOTHER ROOM. CUSTOMER STATES THAT PT SAFETY WAS COMPROMISED DUE TO FACT THAT PT UNDER ANESTHESIA LONGER THAN PROBABLY NECESSARY.
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 |