MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-25 for RADIOLOGY XR7 FILM READER/ FILM RADIOGRAPHIC CS-3 manufactured by Konica Minolta, Inc..
[109544860]
Konica reader shut down due to hard drive failure. Radiology images lost. Patient needed images retaken.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077469 |
| MDR Report Key | 7548987 |
| Date Received | 2018-05-25 |
| Date of Report | 2018-05-23 |
| Date of Event | 2018-05-14 |
| Date Added to Maude | 2018-05-29 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RADIOLOGY XR7 FILM READER/ FILM RADIOGRAPHIC |
| Generic Name | RADIOLOGY XR7 FILM READER/ FILM RADIOGRAPHIC |
| Product Code | IWZ |
| Date Received | 2018-05-25 |
| Model Number | CS-3 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KONICA MINOLTA, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-25 |