MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-02 for DRX-1 TRANSPORTABLE SYSTEM manufactured by Carestream Health, Inc..
| Report Number | 9144771 |
| MDR Report Key | 9144771 |
| Date Received | 2019-10-02 |
| Date of Report | 2019-09-24 |
| Date of Event | 2019-09-18 |
| Report Date | 2019-09-24 |
| Date Reported to FDA | 2019-09-24 |
| Date Reported to Mfgr | 2019-10-02 |
| Date Added to Maude | 2019-10-02 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRX-1 TRANSPORTABLE SYSTEM |
| Generic Name | SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) |
| Product Code | MQB |
| Date Received | 2019-10-02 |
| Returned To Mfg | 2019-09-18 |
| Model Number | DRX-1 |
| Device Availability | R |
| Device Age | 8 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARESTREAM HEALTH, INC. |
| Manufacturer Address | 1049 WEST RIDGE ROAD ROCHESTER NY 14615 US 14615 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-02 |