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U.S. Department of Health and Human Services

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

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SAMSUNG ELECTRONICS CO., LTD GC85A DIGITAL RADIOGRAPHY GC85A Back to Search Results
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.
 
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Brand NameGC85A
Type of DeviceDIGITAL 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 Key6805409
MDR Text Key83099187
Report Number3004938766-2017-00008
Device Sequence Number1
Product Code KPR
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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
Date FDA Received08/18/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Radiologic Technologist
Device Model NumberGC85A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/16/2017
Distributor Facility Aware Date06/15/2017
Device Age6 MO
Event Location Outpatient Diagnostic Facility
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 08/18/2017 Patient Sequence Number: 1
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