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 2012-02-28 for HUT EXT DR FINAL ASSY-STANDARD 404008 manufactured by Liebel-flarsheim Co..
[14888162]
(b)(6): customer reports via phone that an approximately (b)(6) female patient was having a urethroscopy procedure when te system fluoro failed. Staff moved a portable c-arm fluoro unit into the room and the physician completed the procedure without further incident. No reported injury.
Patient Sequence No: 1, Text Type: D, B5
[15278444]
Field service engineer (fse) found the tube warm up and spot working but no fluoro. Troubleshot system finding a damaged wire at the fluoro footswitch connector. Fse repaired damaged wire at connector and checked unit for proper operation per hut service checklist. Unit fully functional. Unit passed checkout procedures and was returned to full service by the customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1518293-2012-00042 |
| MDR Report Key | 2480352 |
| Report Source | 05,06,07 |
| Date Received | 2012-02-28 |
| Date of Report | 2012-02-28 |
| Date of Event | 2012-02-15 |
| Date Mfgr Received | 2012-02-15 |
| Device Manufacturer Date | 2009-03-01 |
| Date Added to Maude | 2012-08-24 |
| 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 | HUT EXT DR FINAL ASSY-STANDARD |
| Product Code | KQS |
| Date Received | 2012-02-28 |
| Model Number | HUT EXT DR |
| Catalog Number | 404008 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2012-02-28 |