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 2011-12-13 for HUT EXT DR FINAL ASSY-REVERSE 404007 manufactured by Liebel-flarsheim Co..
[20790764]
On (b)(6): customer reports staff noted the system failure when starting up room for days procedures. Customer does not have a back up room. Procedures were cancelled by the physician. No reported injury.
Patient Sequence No: 1, Text Type: D, B5
[20966801]
Field service engineer (fse) troubleshot complaint and found the issue was due to a defective infimed video card (graphics board) on their platinum one. Fse replaced infimed video card (graphics board). Fse then verified proper operation using hut dr service manual, sedecal generator service manual, huestis collimator service manual, and the infimed platinum one tech manual. System was returned to full service by the customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1518293-2011-00243 |
| MDR Report Key | 2409977 |
| Report Source | 05,06,07 |
| Date Received | 2011-12-13 |
| Date of Report | 2011-12-13 |
| Date of Event | 2011-12-01 |
| Date Mfgr Received | 2011-12-01 |
| Device Manufacturer Date | 2009-04-01 |
| Date Added to Maude | 2012-07-24 |
| 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 E. 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 | 2011-12-13 |
| Model Number | HUT EXT DR |
| Catalog Number | 404007 |
| 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 E. GALBRAITH RD. CINCINNATI OH 45237 US 45237 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-12-13 |