MAUDE Adverse Event Report: SAMSUNG ELECTRONICS CO., LTD. GM85; DIGITAL DIAGNOSTIC MOBILE X-RAY SYSTEM

Model Number GM85

Device Problem Human-Device Interface Problem (2949)

Patient Problems No Patient Involvement (2645); Patient Problem/Medical Problem (2688)

Event Date 01/02/2020

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: GM85
• Type of Device: DIGITAL DIAGNOSTIC MOBILE X-RAY SYSTEM
• Manufacturer (Section D): SAMSUNG ELECTRONICS CO., LTD.; 129, samsung-ro, yeongtong-gu; suwon-si, 16677 ; KS 16677
• Manufacturer (Section G): SAMSUNG ELECTRONICS CO., LTD.; 129, samsung-ro, yeongtong-gu; suwon-si, gyeonggido 16677 ; KS 16677
• Manufacturer Contact: ninad gujar ; 14 electronics avenue; danvers, MA 01923 ; 9785648632
• MDR Report Key: 9608483
• MDR Text Key: 177344878
• Report Number: 3010300212-2020-00001
• Device Sequence Number: 1
• Product Code: IZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182183
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: GM85
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/20/2020
• Distributor Facility Aware Date: 01/02/2020
• Event Location: Hospital
• Date Report to Manufacturer: 01/07/2020
• Date Manufacturer Received: 01/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization