MAUDE Adverse Event Report: SAMSUNG ELECTRONICS CO., LTD GC85A; DIGITAL RADIOGRAPHY GC85A

Model Number GC85A

Device Problem Use of Device Problem (1670)

Patient Problem Injury (2348)

Event Date 07/13/2017

Event Type  malfunction  

Manufacturer Narrative

No issues were found with table, table top and bucky tray assembly during service inspection.The gap between the table rail and bucky tray assembly is as designed.All respective parts are in good working condition.The issue was determined to be incorrect usage by not using the hand grip, which was reported to the service manager by the supervisor.Therefore, this has been deemed to be an operator error.No further follow up required as the incident ultimately occurred due to (as stated) operator error.

Event Description

Patient was lying on her back on the table for lateral lumbar x-ray.As the patient was positioned to her left side, she grabbed the table top rail with her right hand.Her fingers were wrapped around and under said rail.She was not using a hand grip, as reported by the x-ray technician.As the table top was moved laterally to position the patient over the detector in the table bucky, the patients fingers were pinched between the table top back rail and bucky tray assembly.The patient reacted and told the x-ray technician, who had to move to the table top towards the back wall to release her fingers.No blood or broken bones were reported.

• Brand Name: GC85A
• Type of Device: DIGITAL RADIOGRAPHY GC85A
• Manufacturer (Section D): SAMSUNG ELECTRONICS CO., LTD; 129, samsung-ro, yeongtong-gu; suwon-si, gyeonggi-do, ks 44374 2; KS 443742
• MDR Report Key: 6805409
• MDR Text Key: 83099187
• Report Number: 3004938766-2017-00008
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial
• Report Date: 08/16/2017,08/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Model Number: GC85A
• 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: 08/16/2017
• Distributor Facility Aware Date: 06/15/2017
• Device Age: 6 MO
• Event Location: Outpatient Diagnostic Facility
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/18/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other