MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-29 for HUT EXT DR FINAL ASSY-STANDARD 404008 manufactured by Liebel-flarsheim.
[109757314]
Table is shutting off during cases. Customer states generator screen in the console would go offline as if it lost power, could go over to on/off switch and turn on and it would turn right back on. The 2 monitors on the table were also going black, and could not fluoro. Only way to get back on was to reboot the generator. But today, it was working fine. Main issue - the console/generator is spontaneously shut down, no errors in the log. Nothing per ge fse. Fse reseated several connectors, power relay, etc, and it still shut off. Procedure was not completed and patient was moved to ct and finished. No injuries to patient or staff reported.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1518293-2018-00016 |
MDR Report Key | 7549347 |
Date Received | 2018-05-29 |
Date of Report | 2018-05-29 |
Date of Event | 2018-05-02 |
Date Mfgr Received | 2018-05-02 |
Device Manufacturer Date | 2008-05-31 |
Date Added to Maude | 2018-05-29 |
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 | 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 | 2018-05-29 |
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 | 2018-05-29 |