MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-01-20 for GM85 manufactured by Samsung Electronics Co., Ltd..
[177344878]
Operator mentioned that when she moved the gm85 backwards it did not stop and pinned her against the wall. She was able to slip out from behind the machine. When the elevator ride was over, the machine worked normally without issue. Our service representative checked the machine after the incident, drove it around and tried to reproduce the issue, checked calibration and settings. The noted malfunction was not reproducible as the system did not show anything to be out of the ordinary. The operator felt confident enough to continue using the gm85 system.
Patient Sequence No: 1, Text Type: N, H10
[177344879]
Gm85 operator was pinned against the wall of the elevator that was being used to transport said system to another floor. The system apparently did not stop moving backwards against the operator when it was initially set in that motion to do so, which then pinned said operator. This backwards movement was being done to allow for additional space to be utilized inside the elevator.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010300212-2020-00001 |
| MDR Report Key | 9608483 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-01-20 |
| Date of Report | 2020-01-20 |
| Date of Event | 2020-01-02 |
| Date Facility Aware | 2020-01-02 |
| Report Date | 2020-01-20 |
| Date Reported to FDA | 2020-01-20 |
| Date Reported to Mfgr | 2020-01-07 |
| Date Mfgr Received | 2020-01-07 |
| Date Added to Maude | 2020-01-20 |
| 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 | DR. NINAD GUJAR |
| Manufacturer Street | 14 ELECTRONICS AVENUE |
| Manufacturer City | DANVERS MA 01923 |
| Manufacturer Country | US |
| Manufacturer Postal | 01923 |
| Manufacturer Phone | 9785648632 |
| Manufacturer G1 | SAMSUNG ELECTRONICS CO., LTD. |
| Manufacturer Street | 129, SAMSUNG-RO, YEONGTONG-GU |
| Manufacturer City | SUWON-SI, GYEONGGIDO 16677 |
| Manufacturer Country | KS |
| Manufacturer Postal Code | 16677 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GM85 |
| Generic Name | DIGITAL DIAGNOSTIC MOBILE X-RAY SYSTEM |
| Product Code | IZL |
| Date Received | 2020-01-20 |
| Model Number | GM85 |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SAMSUNG ELECTRONICS CO., LTD. |
| Manufacturer Address | 129, SAMSUNG-RO, YEONGTONG-GU SUWON-SI, 16677 KS 16677 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-01-20 |