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U.S. Department of Health and Human Services

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

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SAMSUNG ELECTRONICS CO., LTD. GC85A DIGITAL DIAGNOSTIC X-RAY SYSTEM Back to Search Results
Model Number GC85A
Device Problem Human-Device Interface Problem (2949)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 04/30/2019
Event Type  Injury  
Event Description
The imaging technologist was positioning gc85a system for upright x-ray images of the patient's knee when the wall stand receptor was lowered down, pinning the patient's foot to the floor. The imaging technologist immediately lifted the unit, releasing the patients foot. After assessment by an orthopedic physician, a diagnostic foot x-ray was performed for the patient. Follow-up mri was also completed, no fracture was seen and contusion was noted for the patient.
 
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Brand NameGC85A
Type of DeviceDIGITAL DIAGNOSTIC X-RAY SYSTEM
Manufacturer (Section D)
SAMSUNG ELECTRONICS CO., LTD.
129, samsung-ro, yeongtong-gu
suwon-si
gyeonggi-do, 16677
KS 16677
MDR Report Key8652531
MDR Text Key146474043
Report Number3004938766-2019-00003
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
Type of Report Initial
Report Date 05/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/29/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberGC85A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/29/2019
Distributor Facility Aware Date04/30/2019
Device Age4 MO
Event Location Hospital
Date Report to Manufacturer05/02/2019
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?
Type of Device Usage

Patient Treatment Data
Date Received: 05/29/2019 Patient Sequence Number: 1
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