MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-25 for HUT EXT DR FINAL ASSY-REVERSE 404007 manufactured by Liebel-flarsheim.
[81128383]
Fse went on site and confirmed that the fluoro image monitor (pn 500272) had gone out. Fse replaced the viewsonic monitor and verified proper operation per service checklist verified operation according to service checklist qssrwi4. 1. The system was fully functional and returned to full service. A review of cts shows last monitor issue reported on this unit was a replacement of the control room monitor (pn 500272) due to a pink hue on the screen.
Patient Sequence No: 1, Text Type: N, H10
[81128384]
Patient on the table, the case was not complete with the system, the patient had to be moved, no injuries or adverse issues noted. The customer indicated they are unable to see images on any of the monitors both monitors over the table and the monitor in the control room.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1518293-2017-00020 |
| MDR Report Key | 6739783 |
| Date Received | 2017-07-25 |
| Date of Report | 2017-07-25 |
| Date of Event | 2017-06-27 |
| Date Mfgr Received | 2017-06-27 |
| Device Manufacturer Date | 2008-06-30 |
| Date Added to Maude | 2017-07-25 |
| 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 |
| Reporter Occupation | RADIOLOGIC TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | FRED RECKELHOFF |
| Manufacturer Street | 2111 E. GALBRAITH RD |
| Manufacturer City | CINCINNATI OH 45237 |
| Manufacturer Country | US |
| Manufacturer Postal | 45237 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HUT EXT DR FINAL ASSY-REVERSE |
| Generic Name | HUT EXT DR FINAL ASSY-REVERSE |
| Product Code | IXR |
| Date Received | 2017-07-25 |
| Model Number | 404007 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIEBEL-FLARSHEIM |
| Manufacturer Address | 2111 E. GALBRAITH RD CINCINNATI OH 45237 US 45237 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-25 |