FDA Adverse Event
Malfunction
Summary report: N
HUTIV FINAL ASSY,STD,LEFT
MDR report key: 2462721
·
Received February 14, 2012
Report
- Report Number
- 1518293-2012-00032
- Event Type
- Malfunction
- Date Received
- February 14, 2012
- Date of Event
- February 4, 2012
- Report Date
- February 14, 2012
- Manufacturer
- LIEBEL-FLARSHEIM CO.
- Product Code
- KQS
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT MONITORING FOLLOW UP: CUSTOMER REPORTS AFTER COMPLETION OF PROCEDURE, THEY RETURNED TO THE ROOM AND THE SYSTEM WAS FUNCTIONAL. THERE IS NO FURTHER PROBLEM WITH THE SYSTEM.
Description of Event or Problem · 1
ON (B)(6): CUSTOMER REPORTS VIA PHONE THAT STAFF WERE PERFORMING A RETROGRADE PYELOGRAM ON A LARGE MALE PATIENT, APPROXIMATELY (B)(6), WHEN THE X-RAY TUBE OVERHEATED DUE TO PHYSICIAN CONSISTENT USE OF FLUORO, SYSTEM LOSING FLUORO CAPABILITY. STAFF MOVED THE PATIENT TO ANOTHER ROOM WHERE THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. NO REPORTED INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HUTIV FINAL ASSY,STD,LEFT | KQS | LIEBEL-FLARSHEIM CO. | HUTIV | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |