MAUDE Adverse Event Report: KONICA MINOLTA HEALTHCARE AMERICAS, INC. AU 4000 U-ARM; SYSTEM, X-RAY, STATIONARY

Model Number SU-4000

Device Problems Self-Activation or Keying (1557); Unintended Movement (3026)

Patient Problem Contusion (1787)

Event Date 09/13/2018

Event Type  Injury  

Event Description

While performing an x-ray, unit moved involuntarily.The techs were performing a lateral hip exam which is set up within the machine for a 90 degree shot.Therefore reasons to get a better image had to perform at 0 degree.While making x-ray, the machine started to move to 90 degrees resulting in table and pt being lifted.The quick thinking and reaction of personel prevented pt from injury.They ran in the room and pulled table with pt on it out of harms way.Then a third technologist hit a button on control at the u-arm to stop the machine.The two technologists who ran into room to help the pt did have some bumps and bruises.As far as i know, no medical attention was needed.Upon arrival tested several ways issue could have happened, including hitting move button while exposing, using remote from other x-ray room at different angles.Also insuring that pt or tech did not accidentally hit any buttons.Called tech support (konica minolta) was told to return in the morning to troubleshoot.On (b)(6) 2018 returned and had tech support on the phone.Most of time on this day was tech support looking into log files and still trying to recreate issue.Was told konica would be sending out an engineer.On (b)(6) 2018 konica showed up.At this point he is lead service engineer with me assisting.We took apart switches and tested remote.Was at a loss at what could have caused issue.On (b)(6) 2018 watched exams being performed in room and after several hours seen it fail.Saw in log that move button was pressed and determined it was sticking.Will replace switches in the morning.With that being said, more troubleshooting has to be done to see why even though move button was stuck, it should not have moved.On (b)(6) 2018 initial call was put into my company ((b)(6)) around 14:15.At that time i called customer once i got word to ensure them i was on the way.I arrived around 15:30.

• Brand Name: AU 4000 U-ARM
• Type of Device: SYSTEM, X-RAY, STATIONARY
• Manufacturer (Section D): KONICA MINOLTA HEALTHCARE AMERICAS, INC. ; garner NC
• MDR Report Key: 7922429
• MDR Text Key: 122194140
• Report Number: MW5080221
• 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: Voluntary
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SU-4000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention