MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-03 for INFIMED, NEXUS IMAGE PROC SYS 710330 manufactured by Liebel-flarsheim.
[132494639]
This incident was reported on (b)(6) 2018 as communication error in regards to the software in an lf direct digital imaging system. The reporter stated that the event occurred during a procedure, where the fluoro suddenly stopped working. Reporter states that it was an image acquisition issue and believes it stems from a software problem. The ra/qa manager who is reporting this incident stated that this was a communication error and that the list system monitor was displaying a black screen, and that it occurred during a procedure but there was no harm to the patient. Awaiting investigation results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1518293-2018-00045 |
| MDR Report Key | 8214751 |
| Date Received | 2019-01-03 |
| Date of Report | 2018-12-06 |
| Date of Event | 2018-11-27 |
| Date Mfgr Received | 2018-12-06 |
| Date Added to Maude | 2019-01-03 |
| 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 | RISK MANAGER |
| 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 | INFIMED, NEXUS IMAGE PROC SYS |
| Generic Name | INFIMED, NEXUS IMAGE PROC SYS |
| Product Code | MQB |
| Date Received | 2019-01-03 |
| Model Number | 710330 |
| 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 | 2019-01-03 |