MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC DEFINIUM 8000; SYSTEM, X-RAY, STATIONARY

Model Number 8000

Device Problems Component Falling (1105); Positioning Problem (3009)

Patient Problem Injury (2348)

Event Date 05/27/2016

Event Type  malfunction  

Event Description

An employee obtained a patient from the waiting room.When the patient turned to do the lateral chest x-ray, he reached up and grabbed the patient support bar.At that time the detector went to a -2, so in order to move the detector into an upright position where it would shoot that image the employee asked the patient to move just a little bit, grabbed the release bar and braced it with the employee's right hand as what's normally done to move it back into a 0 degree placement.At that time, the detector fell forward, the bar came down on the patient's head, and the employee caught the brunt of the forward motion with the employee's arm.The employee immediately asked the patient if he was ok, he said "yes, i am fine, knocked a little sense into me." the employee asked him if she could get him ice and over and over asked if he was ok and he said, "yes i am," and employee apologized numerous times also.The employee completed the exam and upon releasing the patient again verified with him that he was fine, there were no issues and he again replied and said, "i'm fine," and he continued on his way.The employee's shoulder is now hurt and is being seen by employee health from this event.

• Brand Name: DEFINIUM 8000
• Type of Device: SYSTEM, X-RAY, STATIONARY
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3000 north grandview blvd.; waukesha WI 53188
• MDR Report Key: 5916965
• MDR Text Key: 53626167
• Report Number: 5916965
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/17/2016
• Event Location: Hospital
• Date Report to Manufacturer: 08/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63 YR