MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-08-21 for DEFINIUM 8000 DIGITAL RADIOGRAPHIC IMAGING SYSTEM 2374870 manufactured by Ge Medical Systems, Llc.
| Report Number | 2126677-2019-00010 |
| MDR Report Key | 8915659 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-08-21 |
| Date of Report | 2019-09-30 |
| Date of Event | 2019-07-17 |
| Date Mfgr Received | 2019-09-20 |
| Device Manufacturer Date | 1970-01-01 |
| Date Added to Maude | 2019-08-21 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STEVEN WALCZAK |
| Manufacturer Street | 3000 NORTH GRANDVIEW BOULEVARD |
| Manufacturer City | WAUKESHA WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEFINIUM 8000 DIGITAL RADIOGRAPHIC IMAGING SYSTEM |
| Generic Name | SYSTEM, X-RAY, STATIONARY |
| Product Code | KPR |
| Date Received | 2019-08-21 |
| Model Number | 2374870 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE MEDICAL SYSTEMS, LLC |
| Manufacturer Address | 3000 NORTH GRANDVIEW BOULEVARD WAUKESHA, WI 53188 US 53188 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2019-08-21 |