MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-06-24 for COMPUTED RADIOGRAPHY READER FCR XG5000 CR-IR-362 manufactured by Fuji Medical System.
[5866306]
Xray monitor stopped working; would not turn on.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4877582 |
| MDR Report Key | 4877582 |
| Date Received | 2015-06-24 |
| Date of Report | 2015-06-24 |
| Date of Event | 2015-01-09 |
| Report Date | 2015-06-24 |
| Date Reported to FDA | 2015-06-24 |
| Date Reported to Mfgr | 2015-06-30 |
| Date Added to Maude | 2015-06-30 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMPUTED RADIOGRAPHY READER |
| Generic Name | PROCESSOR, RADIOGRAPHIC FILM, AUTOMATIC |
| Product Code | IXW |
| Date Received | 2015-06-24 |
| Model Number | FCR XG5000 |
| Catalog Number | CR-IR-362 |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FUJI MEDICAL SYSTEM |
| Manufacturer Address | 419 WEST AVENUE STAMFORD CT 06902 US 06902 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-24 |