MAUDE Adverse Event Report: SAMSUNG ELECTRONICS CO, LTD GC85A; DIGITAL DIAGNOSTIC X-RAY SYSTEM,

Model Number GC85A

Device Problem Unintended System Motion (1430)

Patient Problem Limb Fracture (4518)

Event Date 10/21/2021

Event Type  malfunction  

Event Description

The customer reported that while setting up a patient for a scan, the test sensors on the safety arm of the device were not enabled.The movement of the device continued onto the patient's foot.No further information on patient injury was received at the time of the initial complaint.

Manufacturer Narrative

After review by neurologica's field service representative, it was stated that the safety sensor of the device did not go on and the device movement continued, and as a result came down to patients foot.It was clarified that after the patient was examined, no injury resulted from this incident.The field service representative determined that one of the sensor settings was not on, which caused the device's movement.The sensors were enabled and tested and found to be working appropriately.The customer stated that they will be filing an incident report and the above narrative adds context to the report submitted by the hospital.There was no user harm (patient or operator), and this incident is estimated to happen due to a user-induced issue.Future service calls will be monitored to ensure there is no trend in similar incidents.

• Brand Name: GC85A
• Type of Device: DIGITAL DIAGNOSTIC X-RAY SYSTEM,
• Manufacturer (Section D): SAMSUNG ELECTRONICS CO, LTD; 129, samsung-ro, yeongtong-gu; suwon-si, gyeonggido 16677 ; KS 16677
• Manufacturer (Section G): SAMSUNG ELECTRONICS CO., LTD.; 129, samsung-ro yeongtong-gu; suwon-si, gyeonggido 16677 ; KS 16677
• Manufacturer Contact: jeongwoo kim ; 129, samsung-ro yeongtong-gu; suwon-si, gyeonggido 16677 ; KS 16677
• MDR Report Key: 12981880
• MDR Text Key: 285471953
• Report Number: 3010300212-2021-00008
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181629
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GC85A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1