FDA Adverse Event Injury Summary report: N

AU 4000 U-ARM

MDR report key: 7922429 · Received October 1, 2018

Report

Report Number
MW5080221
Event Type
Injury
Date Received
October 1, 2018
Date of Event
September 13, 2018
Report Date
September 18, 2018
Manufacturer
KONICA MINOLTA HEALTHCARE AMERICAS, INC.
Product Code
KPR
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
SC, US
Reporter Occupation
BIOMEDICAL ENGINEER

Narratives

Description of Event or Problem · 1

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.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
765568 AU 4000 U-ARM SYSTEM, X-RAY, STATIONARY KPR KONICA MINOLTA HEALTHCARE AMERICAS, INC. SU-4000

Patients

Seq Age Sex Outcome Treatment
1 Required Intervention