MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-11-06 for DRX-REVOLUTION MOBILE X-RAY SYSTEM manufactured by Carestream Health Inc..
| Report Number | 1317307-2019-00004 |
| MDR Report Key | 9284795 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-11-06 |
| Date of Report | 2019-11-05 |
| Date of Event | 2019-10-10 |
| Device Manufacturer Date | 2013-10-10 |
| Date Added to Maude | 2019-11-06 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MISS NANCY MEJIAS |
| Manufacturer Street | 150 VERONA STREET |
| Manufacturer City | ROCHESTER 14608 |
| Manufacturer Country | US |
| Manufacturer Postal | 14608 |
| Manufacturer Phone | 5856278533 |
| Manufacturer G1 | CARESTREAM HEALTH INC. |
| Manufacturer Street | 1049 RIDGE ROAD WEST |
| Manufacturer City | ROCHESTER NY 14615 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14615 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRX-REVOLUTION MOBILE X-RAY SYSTEM |
| Generic Name | DRX-REVOLUTION MOBILE X-RAY SYSTEM |
| Product Code | IZL |
| Date Received | 2019-11-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARESTREAM HEALTH INC. |
| Manufacturer Address | 150 VERONA STREET ROCHESTER NY 14608 US 14608 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-06 |