MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-31 for HUT EXT DR FINAL ASSY-STANDARD 404008 manufactured by Liebel-flarsheim.
[119661507]
Field service engineer (fse) went on site to investigate customer's report that during a case the system would not allow fluoro. When the fse arrived, he found the system was fully functional. The fse could not duplicate the no fluoro issue as he was able to fluoro and perform digital spot without any problem. Varex review of the logs pulled from the imaging computer found no issue recorded. Fse spoke to the x-ray tech who experienced the issue who said that a "fault alarm reset" message was seen flashing on the generator console during the time that the fluoro had stopped, and that she had shutoff generator console and issue was resolved. When a generator fault alarm occurs on this system, the generator will not allow further exposures until the fault alarm is acknowledged by the operator, either by touching the flashing button that says "fault alarm reset", or as in this case, by the operator who power cycled the generator. Both result in resetting the fault alarm and resetting the generator. After the fault alarm reset, the generator will again allow fluoro / exposures. The operator did not note that alarm was in the `error center' of the generator console when the fault alarm reset button was flashing. It is not known what caused this fault alarm, as it may have been due to an operator error with the foot pedal as surmised by the fse or could have been due to an issue in the generator. System remained in full service. After investigating the system, the fse verified operation according to hut dr service checklist qssrwi4. 1 and returned the unit to full service.
Patient Sequence No: 1, Text Type: N, H10
[119661508]
Incident: lft htdr x-ray/fluoro issues - stopped flouring. During a case the system would not allow fluoro. The x-ray tech who experienced the issue who said that a "fault alarm reset" message was seen flashing on the generator console during the time that the fluoro had stopped, and that she had shutoff generator console and issue was resolved. The operator did not note what alarm was in the `error center' of the generator console when the fault alarm reset button was flashing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1518293-2018-00029 |
| MDR Report Key | 7836761 |
| Date Received | 2018-08-31 |
| Date of Report | 2018-08-03 |
| Date of Event | 2018-08-03 |
| Date Mfgr Received | 2018-07-24 |
| Device Manufacturer Date | 2011-04-30 |
| Date Added to Maude | 2018-08-31 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | FRED RECKELHOFF |
| Manufacturer Street | 2111 E GALBRAITH ROAD |
| 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 | 2018-08-31 |
| 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 ROAD CINCINNATI OH 45237 US 45237 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-31 |