MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-16 for HUT EXT DR FINAL ASSY-STANDARD 404008 manufactured by Liebel-flarsheim.
[77940665]
Sedecal integrated console display out. Patient was on the table and the sedecal integrated console went blank. Reboots of the console would not bring up the screen. Patient had to be moved to another room. There was a "foob" for the console. Intermittently generator console (old style) freezes and will not reboot. New console will not power on/off generator. The first replacement console was reported as a failure out of box and returned to lf for evaluation on rga 57221811. Evaluation of this console was done by r and d ((b)(6)) who found that the console would power on but not turn on the generator. Further investigation found cause was a broken c1 capacitor on the `turn on' pcb located at the bottom of the console enclosure. The console was returned to sedecal for repair.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1518293-2017-00017 |
| MDR Report Key | 6646695 |
| Date Received | 2017-06-16 |
| Date of Report | 2017-06-16 |
| Date of Event | 2017-05-19 |
| Date Mfgr Received | 2017-05-19 |
| Device Manufacturer Date | 2012-12-31 |
| Date Added to Maude | 2017-06-16 |
| 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 |
| 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-STANDARD |
| Generic Name | HUT EXT DR FINAL ASSY-STANDARD |
| Product Code | IXR |
| Date Received | 2017-06-16 |
| Model Number | 404008 |
| 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 | 2017-06-16 |