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U.S. Department of Health and Human Services

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

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SAMSUNG ELECTRONICS CO., LTD. GC85A GC85A DIGITAL RADIOGRAPHY Back to Search Results
Model Number DGR-C58JAB/WR
Device Problems Improper or Incorrect Procedure or Method (2017); Device Handling Problem (3265)
Patient Problems Abrasion (1689); Bruise/Contusion (1754)
Event Date 03/29/2016
Event Type  Injury  
Manufacturer Narrative
This was caused due to careless use by the operator and the device was not the contributory cause of the incident. Retraining has been provided to the user. The "park" button since this occurrence has been reprogrammed to prevent any table movement to the patient support. Customers narrative indicates that they appear satisfied with this solution. Future design enhancements to the benefit of patient safety are being reviewed and discussed.
 
Event Description
An (b)(6) woman in a wheel chair was rolled into the room for an exam. The technologist placed the patient in the wheel chair underneath the gc85a table for an upper extremity exam. The x-ray technologist (user) pressed the park button by mistake causing the table to move down onto the patient. The force of the table caused bruising and a puncture wound to the patient's legs requiring medical attention.
 
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Brand NameGC85A
Type of DeviceGC85A DIGITAL RADIOGRAPHY
Manufacturer (Section D)
SAMSUNG ELECTRONICS CO., LTD.
129, samsung-ro, yeongtong-gu
suwon-si, gyeonggi-do
443-7 42
KS 443-742
MDR Report Key5608892
MDR Text Key43666128
Report Number3004938766-2016-00001
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 04/26/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Radiologic Technologist
Device Model NumberDGR-C58JAB/WR
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/26/2016
Distributor Facility Aware Date03/29/2016
Device Age1 YR
Event Location Hospital
Date Report to Manufacturer04/15/2016
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: 04/26/2016 Patient Sequence Number: 1
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