MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-02 for CLEARCANVAS RIS/PACS PERSONAL EDITION WORKSTATION 13.1 SYN-0524 manufactured by Synaptive Medical Inc..
| Report Number | 3012075008-2020-00003 |
| MDR Report Key | 9777552 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-02 |
| Date of Report | 2020-03-02 |
| Date of Event | 2017-06-13 |
| Date Mfgr Received | 2020-02-04 |
| Device Manufacturer Date | 2017-11-06 |
| Date Added to Maude | 2020-03-02 |
| 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 MAHAM ANSARI |
| Manufacturer Street | 555 RICHMOND STREET W SUITE 800 |
| Manufacturer City | TORONTO, ONTARIO M5V3B1 |
| Manufacturer Country | CA |
| Manufacturer Postal | M5V3B1 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLEARCANVAS RIS/PACS |
| Generic Name | SYSTEM, IMAGE PROCESSING, RADIOLOGICAL |
| Product Code | LLZ |
| Date Received | 2020-03-02 |
| Model Number | PERSONAL EDITION WORKSTATION 13.1 |
| Catalog Number | SYN-0524 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNAPTIVE MEDICAL INC. |
| Manufacturer Address | 555 RICHMOND STREET W SUITE 800 TORONTO, ONTARIO M5V3B1 CA M5V3B1 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-02 |