FDA Adverse Event
Malfunction
Summary report: N
HUT EXT DR FINAL ASSY-STANDARD
MDR report key: 2063110
·
Received March 22, 2011
Report
- Report Number
- 1518293-2011-00047
- Event Type
- Malfunction
- Date Received
- March 22, 2011
- Date of Event
- March 2, 2011
- Report Date
- March 2, 2011
- Manufacturer
- LIEBEL-FLARSHEIM CO.
- Product Code
- KQS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FIELD SERVICE ENGINEER TROUBLESHOT SYSTEM BUT WAS UNABLE TO REPRODUCE THE REPORTED PROBLEM OF 'NO FLUORO' DURING THIS INVESTIGATION. FSE DECIDED TO REPLACE THE ATP CONSOLE BOARD AS A PREVENTIVE MEASURE AND CHECKED FOR PROPER OPERATION PER HUT SERVICE CHECKLIST. UNIT PASSED CHECKOUT PROCEDURES AND WAS RETURNED TO FULL SERVICE BY THE CUSTOMER.
Description of Event or Problem · 1
ON (B)(6): STAFF REPORTS THE SYSTEM FLUORO DID FAIL DURING A PT PROCEDURE, BUT WOULD PROVIDE NO PT OR PROCEDURAL INFO WITH REGARDS TO THIS EVENT. NO REPORTED INJURY.
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 |