MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-07-25 for CARESTREAM DRX REVOLUTION MOBILE X-RAY SYSTEM DRX-R-1 1019397 manufactured by Carestream Health Inc.
| Report Number | 1317307-2019-00003 |
| MDR Report Key | 8826929 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-07-25 |
| Date of Report | 2019-07-25 |
| Date of Event | 2019-05-01 |
| Date Mfgr Received | 2019-06-28 |
| Date Added to Maude | 2019-07-25 |
| 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 | MS. NANCY MEJIAS |
| Manufacturer Street | 150 VERONA STREET |
| Manufacturer City | ROCHESTER NY 14608 |
| Manufacturer Country | US |
| Manufacturer Postal | 14608 |
| Manufacturer G1 | CARESTREAM HEALTH INC |
| Manufacturer Street | 1049 RIDGE ROAD |
| Manufacturer City | ROCHESTER 14615 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14615 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARESTREAM DRX REVOLUTION MOBILE X-RAY SYSTEM |
| Generic Name | DRX REVOLUTION |
| Product Code | IZL |
| Date Received | 2019-07-25 |
| Model Number | DRX-R-1 |
| Catalog Number | 1019397 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 1. Other | 2019-07-25 |