MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2011-11-17 for HUT EXT DR FINAL ASSY-STANDARD 404008 manufactured by Liebel-flarsheim Co..
[17873119]
(b)(6): customer reports that a (b)(6) male pt was undergoing a cystoscopy procedure with stent placement when the system fluoro failed. Physician completed the procedure using endoscopy. No reported injury.
Patient Sequence No: 1, Text Type: D, B5
[18022122]
Covidien tech support advised customer that there was a possible fuse blown in the main generator cabinet or a k6 relay issue. Customer then said they wanted their own in-house biomed to look at the issue first. Tech support follow up call; the customer said their biomed worked on the system, but she does not know what he did. However, the system is now fully functional. (b)(6): product monitoring follow up: facility biomed reports they had third party service vendor check out the room. Service found some debris in the electrical cabinet and a blown fuse. Fuse was replaced and the room is functioning without issues. No reported problems.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1518293-2011-00227 |
| MDR Report Key | 2363638 |
| Report Source | 05,06,07 |
| Date Received | 2011-11-17 |
| Date of Report | 2011-10-31 |
| Date of Event | 2011-10-31 |
| Date Mfgr Received | 2011-10-31 |
| Date Added to Maude | 2012-07-16 |
| 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 Phone | 5139485719 |
| Manufacturer G1 | LIEBEL-FLARSHEIM BUSINESS |
| Manufacturer Street | 2111 EAST GALBRAITH RD. |
| Manufacturer City | CINCINNATI OH 45237 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 45237 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUT EXT DR FINAL ASSY-STANDARD |
| Generic Name | UROLOGY SUITE |
| Product Code | KQS |
| Date Received | 2011-11-17 |
| Model Number | HUT EXT DR |
| Catalog Number | 404008 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2011-11-17 |