MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-29 for GC85A manufactured by Samsung Electronics Co., Ltd..
[146474043]
The imaging technologist was positioning gc85a system for upright x-ray images of the patient's knee when the wall stand receptor was lowered down, pinning the patient's foot to the floor. The imaging technologist immediately lifted the unit, releasing the patients foot. After assessment by an orthopedic physician, a diagnostic foot x-ray was performed for the patient. Follow-up mri was also completed, no fracture was seen and contusion was noted for the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004938766-2019-00003 |
| MDR Report Key | 8652531 |
| Date Received | 2019-05-29 |
| Date of Report | 2019-05-29 |
| Date of Event | 2019-04-30 |
| Date Facility Aware | 2019-04-30 |
| Report Date | 2019-05-29 |
| Date Reported to FDA | 2019-05-29 |
| Date Reported to Mfgr | 2019-05-02 |
| Date Added to Maude | 2019-05-29 |
| 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 | 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 | GC85A |
| Generic Name | DIGITAL DIAGNOSTIC X-RAY SYSTEM |
| Product Code | KPR |
| Date Received | 2019-05-29 |
| Model Number | GC85A |
| Device Availability | N |
| Device Age | 4 MO |
| 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 GYEONGGI-DO, 16677 KS 16677 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-29 |