MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-11 for GU60A manufactured by Samsung Electronics Co., Ltd..
| Report Number | 3004938766-2019-00006 |
| MDR Report Key | 9180862 |
| Date Received | 2019-10-11 |
| Date of Report | 2019-10-11 |
| Date of Event | 2018-12-14 |
| Date Facility Aware | 2018-12-17 |
| Report Date | 2018-12-18 |
| Date Reported to FDA | 2018-12-18 |
| Date Reported to Mfgr | 2018-12-17 |
| Date Added to Maude | 2019-10-11 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GU60A |
| Generic Name | DIGITAL DIAGNOSTIC X-RAY SYSTEM |
| Product Code | KPR |
| Date Received | 2019-10-11 |
| Model Number | GU60A |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SAMSUNG ELECTRONICS CO., LTD. |
| Manufacturer Address | 129, SAMSUNG-RO, YEONGTONG-GU SUWON-SI, GYEONGGIDO 16677 KS 16677 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-10-11 |