MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-11 for HUT EXT DR FINAL ASSY-REVERSE 404007 manufactured by Liebel-flarsheim.
[133190443]
This incident was reported on (b)(6) 2018 as a device malfunction resulting in no images when stepping on fluoro foot pedal. The reporter stated that an error image was not taken, and that release foot pedal sedecal screen was powered off. The event did occur during a procedure and the procedure was not completed and had to be rescheduled. Reporter stated that the sedecal console is shutting down during the attempted exposures, and phone call receiver requested that reporter attempt to take an exposure and the message center showed check collimator. Phone call receiver had reporter turn pbl override, which resulted in successful exposure, then turned back system returned to normal operation. Following this, the reporter called back on (b)(6) 2018 and stated that the facility has not had any issues from the last call until the day of the follow-up call, and stated that the sedecal touch screen, the older one, turned itself off again. The reporter was told that the fix would be a sedecal console upgrade.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1518293-2018-00046 |
| MDR Report Key | 8240669 |
| Date Received | 2019-01-11 |
| Date of Report | 2018-12-11 |
| Date of Event | 2018-12-11 |
| Date Mfgr Received | 2018-12-11 |
| Device Manufacturer Date | 2012-08-31 |
| Date Added to Maude | 2019-01-11 |
| 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 |
| 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-REVERSE |
| Generic Name | HUT EXT DR FINAL ASSY-REVERSE |
| Product Code | IXR |
| Date Received | 2019-01-11 |
| 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 ROAD CINCINNATI OH 45237 US 45237 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-11 |