MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2011-11-22 for HUTIV FINAL ASSY, STD, LEFT HUT ES 400002 manufactured by Liebel-flarsheim Co..
[2507134]
On (b)(6): customer reports that during an undetermined urology procedure the sys fluoro failed. Staff moved the pt to a back up room where procedure was completed without further incident. Customer did not provide any pt or procedural info other than to say the procedure was completed, no reported injury.
Patient Sequence No: 1, Text Type: D, B5
[9493352]
Covidien technical support began troubleshooting with biomed thinking the probable issue was the cpu pcb board. After trying several things over days of calls between biomed and tech support, including switching out the cpu pcb from another old unit in house, it was determined the actual problem was a blown pico fuse (3 amp f1) on the harness distribution board. There are no parts available for this sys. Tech support f/u; biomed reported that he replaced the 3 amp pico fuse himself and now the table is up and fully functional.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1518293-2011-00228 |
| MDR Report Key | 2363092 |
| Report Source | 06,07 |
| Date Received | 2011-11-22 |
| Date of Report | 2011-11-01 |
| Date of Event | 2011-11-01 |
| Date Mfgr Received | 2011-11-01 |
| Device Manufacturer Date | 1993-05-01 |
| Date Added to Maude | 2012-07-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DAVID BENSON |
| Manufacturer Street | 2111 EAST GALBRAITH RD. |
| Manufacturer City | CINCINNATI OH 45237 |
| Manufacturer Country | US |
| Manufacturer Postal | 45237 |
| Manufacturer Phone | 5139485719 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUTIV FINAL ASSY, STD, LEFT |
| Generic Name | UROLOGY SUITE |
| Product Code | KQS |
| Date Received | 2011-11-22 |
| Model Number | HUT ES |
| Catalog Number | 400002 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIEBEL-FLARSHEIM CO. |
| Manufacturer Address | 2111 EAST GALBRAITH RD. CINCINNATI OH 45237 US 45237 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-22 |