MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-21 for HUT EXT DR FINAL ASSY,RE,FPD 414007 manufactured by Liebel-flarsheim.
[146664450]
This incident was reported on (b)(6) 2019, as the system is unable to acquire images when fluoro. This incident occurred during a procedure where the patient was connected. The procedure was not completed, and there was no injury to the patient or staff. The reporter states that the system is unable to acquire images when fluoroing, and reported it as an intermittent issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1518293-2019-00008 |
| MDR Report Key | 8627806 |
| Date Received | 2019-05-21 |
| Date of Report | 2019-04-22 |
| Date of Event | 2019-04-22 |
| Date Mfgr Received | 2019-04-22 |
| Device Manufacturer Date | 2014-08-31 |
| Date Added to Maude | 2019-05-21 |
| 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 | BIOMEDICAL ENGINEER |
| 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,RE,FPD |
| Generic Name | HUT EXT DR FINAL ASSY,RE,FPD |
| Product Code | MQB |
| Date Received | 2019-05-21 |
| Model Number | 414007 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-05-21 |