MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-26 for HUT EXT DR FINAL ASSY-STANDARD 404008 manufactured by Liebel-flarsheim.
[106882317]
When in a procedure: they were using the fluoro pedal and they took their foot off the pedal and it would not stop fluoroing. The staff had to hit the emergency stop button. They stated this is not the first time this has happened. No adverse effects on patients and the procedure was completed without further incident.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1518293-2018-00011 |
MDR Report Key | 7463846 |
Date Received | 2018-04-26 |
Date of Report | 2018-04-26 |
Date of Event | 2018-03-29 |
Date Mfgr Received | 2018-03-29 |
Device Manufacturer Date | 2006-01-31 |
Date Added to Maude | 2018-04-26 |
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 | 2018-04-26 |
Model Number | 404008 |
Operator | OTHER HEALTH CARE 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 | 2018-04-26 |