MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-11-29 for HUT EXT DR FINAL ASSY-REVERSE 404007 manufactured by Liebel-flarsheim Co..
[2399050]
(b)(6): customer reports via phone that during an unknown urology procedure, the fluoro monitor failed and staff brought in a portable c-arm fluoro unit to complete the procedure. Customer did not provide patient information, but reports the procedure was completed without further incident. No reported injury.
Patient Sequence No: 1, Text Type: D, B5
[9600713]
Customer reported to product monitoring (pm) a table lcd monitor power supply had failed. Product monitoring confirmed the customer resolved this issue by replacing the power supply. Customer reported to product monitoring that there was no need for covidien service.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1518293-2011-00225 |
| MDR Report Key | 2397217 |
| Report Source | 06 |
| Date Received | 2011-11-29 |
| Date of Report | 2011-11-10 |
| Date of Event | 2011-11-09 |
| Date Mfgr Received | 2011-11-10 |
| Device Manufacturer Date | 2003-09-01 |
| 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 | HUT EXT DR FINAL ASSY-REVERSE |
| Generic Name | UROLOGY SUITE |
| Product Code | KQS |
| Date Received | 2011-11-29 |
| Model Number | HUT EXT DR |
| Catalog Number | 404007 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2011-11-29 |