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 HUT EXT DR FINAL ASSY-REVERSE 404007 manufactured by Liebel-flarsheim Co..
[21290788]
On (b)(6): customer reported loss fo fluoro during a procedure to covidien svc technical support. Multiple attempts to contact customer for info have been unsuccessful. If new info is received this report will be updated.
Patient Sequence No: 1, Text Type: D, B5
[21521250]
Covidien technical support advised biomed to reset defaults on the sedecal generator as the sys was set to rad only. Biomed did this but still no fluoro. Next step was to have biomed reset the gim box, table, p1 and reboot sedecal once room was cleared. Biomed will try to call back if needed. Tech support f/u: biomed said that after changing the sedecal configuration to rad/fluoro and rebooting the complete sys the issue was resolved. Sys is now fully functional.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1518293-2011-00230 |
| MDR Report Key | 2363161 |
| Report Source | 06,07 |
| Date Received | 2011-11-22 |
| Date of Report | 2011-10-27 |
| Date of Event | 2011-10-27 |
| Date Mfgr Received | 2011-10-27 |
| Device Manufacturer Date | 2004-02-01 |
| 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 | 0 |
| 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 | 2011-11-22 |
| Model Number | HUT EXT DR |
| Catalog Number | 404007 |
| 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 | 2011-11-22 |