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

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.

• Brand Name: GC85A
• Type of Device: GC85A 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 Key: 5608892
• MDR Text Key: 43666128
• Report Number: 3004938766-2016-00001
• 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: Health Professional
• Type of Report: Initial
• Report Date: 04/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Radiologic Technologist
• Device Model Number: DGR-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 FDA: 04/26/2016
• Distributor Facility Aware Date: 03/29/2016
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/15/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/26/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR