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..
[2510559]
(b)(6): customer reports via e-mail; the system failed to boot up. We could not do fluoro and had to complete the cases without fluoro. We were conducting (b)(6) studies. No pts were harmed, however, we provided sub optimal service to one of the pts as fluoro was a key component of his eval. (b)(6): customer reports via e-mail; (b)(6). Yes, we performed studies despite failure. No reported injury.
Patient Sequence No: 1, Text Type: D, B5
[9564863]
Pending investigation. Upon receipt of investigation, a medwatch 3500a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1518293-2011-00218 |
| MDR Report Key | 2363640 |
| Report Source | 05,06,07 |
| Date Received | 2011-11-17 |
| Date of Report | 2011-10-21 |
| Date of Event | 2011-10-10 |
| Date Mfgr Received | 2011-10-21 |
| Device Manufacturer Date | 2005-04-01 |
| 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 CO. |
| 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 | 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 | 2011-11-17 |