MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2011-12-16 for HUT EXT DR FINAL ASSY-REVERSE 404007 manufactured by Liebel-flarsheim Co..
[2568721]
On (b)(6): customer reports via phone that a (b)(6) pt under general anesthesia was having a stent placement procedure when the system fluoro failed. Pt was moved to another room where physician was able to complete the procedure w/o further incident. No reported injury.
Patient Sequence No: 1, Text Type: D, B5
[9581556]
Field service engineer (fse) was unable to turn on infimed as it did not fully boot up and had a gray screen. Fse ordered a new harddrive from infimed with software loaded to equipment, following infimed system's hard drive replacement procedure (b)(4). Fse restored system settings and loaded pacs info. Fse then was able to complete system checkout using service checklist qssrwi4. 1 and returned system to full service.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1518293-2011-00240 |
| MDR Report Key | 2412201 |
| Report Source | 06,07 |
| Date Received | 2011-12-16 |
| Date of Report | 2011-11-30 |
| Date of Event | 2011-11-30 |
| Date Mfgr Received | 2011-11-30 |
| Device Manufacturer Date | 2004-08-01 |
| Date Added to Maude | 2012-07-25 |
| 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 | 0 |
| 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 | 2011-12-16 |
| Model Number | HUT EXT DR |
| Catalog Number | 404007 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2011-12-16 |