BEUDAMED
    FDA Adverse Event Death Summary report: N

    AZURION

    MDR report key: 12873668 · Received November 25, 2021

    Report

    Report Number
    3003768277-2021-10249
    Event Type
    Death
    Date Received
    November 25, 2021
    Date of Event
    October 31, 2021
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838099241
    PMA / PMN Number
    K200917
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDTL NARRATIVE: PHILIPS HAS INVESTIGATED THIS EVENT. ACCORDING TO THE ADDITIONAL INFORMATION COLLECTED, AT 06:42 THE PATIENT CODED, AND CPR WAS INITIATED. THE PATIENT PASSED AWAY AT 07:12. PHILIPS HAS UNDERTAKEN A GOOD FAITH EFFORT TO GET FURTHER INFORMATION REGARDING THE CONTRIBUTION OF THE SYSTEM TO THE PATIENT OUTCOME. THE CUSTOMER CONFIRMED THAT THE LOSS OF MOTORIZED MOVEMENTS DID NOT CONTRIBUTE TO THE PATIENT OUTCOME, AS IT WAS ABLE TO PULL THE C-ARM AWAY MANUALLY. HOWEVER, THE CUSTOMER WAS NOT ABLE TO PROVIDE FURTHER DETAILS ON THE CONTRIBUTION OF THE CUSTOMER¿S INABILITY TO CHANGE THE TABLE HEIGHT TO THE PATIENT¿S OUTCOME. THEREFORE, IT REMAINS UNKNOWN IF THE CUSTOMER¿S INABILITY TO CHANGE THE TABLE HEIGHT CONTRIBUTED TO THE PATIENT OUTCOME IN ANY WAY. ANALYSIS PERFORMED BY PHILIPS CONCLUDES THAT THE INABILITY TO CHANGE THE TABLE HEIGHT AND LOSS OF MOTORIZED MOVEMENTS HAD TWO DIFFERENT CAUSES: - TABLE HEIGHT ADJUSTMENT ANALYSIS OF THE LOG FILE SHOWED THAT, AFTER CPR WAS INITIATED, BETWEEN 06:47 AND 07:06, TABLE HEIGHT MOVEMENT WAS NOT POSSIBLE AS THE SYSTEM DETECTED COLLISIONS. IT CANNOT BE VERIFIED THROUGH LOG FILE ANALYSIS IF THE COLLISIONS WERE CAUSED BY THE SYSTEM OR PERSONS STANDING TOO CLOSE. THE INSTRUCTIONS FOR USE EXPLAIN THAT THE USER CAN OVERRIDE THE COLLISION PREVENTION FUNCTIONS WHEN THE MOVEMENT IS BLOCKED, BY RELEASING THE MOVEMENT SWITCH AND REACTIVATING IT WITHIN 5 SECONDS. IT IS UNKNOWN IF THE USER ATTEMPTED TO USE THIS OVERRIDE FUNCTION. A PHILIPS SERVICE ENGINEER INSPECTED THE SYSTEM ONSITE, BUT HE WAS NOT ABLE TO REPRODUCE THE REPORTED TABLE HEIGHT MOVEMENT PROBLEM. AS A PRECAUTIONARY MEASURE, THE ENGINEER REPLACED THE TABLE BASE CONNECTION BOX AND TTCF BOARD 1GB. - LOSS OF MOTORIZED MOVEMENTS ANALYSIS OF THE LOG FILE SHOWED THAT, AFTER CPR WAS INITIATED, AT 07:00, THE USER REQUESTED A LONGITUDINAL BEAM MOVEMENT, WHICH WAS NOT POSSIBLE DUE TO A MOTOR ASSEMBLY ERROR. OTHER MOTORIZED C-ARM MOVEMENTS, LIKE ROTATIONAL MOVEMENTS WERE STILL AVAILABLE, AND THE LONGITUDINAL MOVEMENT COULD AND WAS EXECUTED MANUALLY. THE PHILIPS SERVICE ENGINEER WAS ABLE TO REPRODUCE THIS ISSUE AND REPLACED THE CLEA2 LONGITUDINAL DRIVE ASSEMBLY AND THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER ----------------- CORRECTED DATA: THE INITIAL REPORT REFLECTED TWO ISSUES: INABILITY TO CHANGE THE TABLE HEIGHT AND LOSS OF MOTORIZED MOVEMENTS. AFTER INVESTIGATION IT HAS BEEN CONCLUDED THAT THE ISSUES ARE UNRELATED, MAKING THIS A SPLIT COMPLAINT. IN THIS REPORT BOTH ISSUES ARE ADDRESSED, BUT THE RELATED COMPLAINT IS REGARDING THE TABLE ISSUES. THE LOSS OF MOTORIZED MOVEMENT IS CONSIDERED NOT REPORTABLE AS IT HAS BEEN CONFIRMED THAT THE LOSS OF LONGITUDINAL MOTORIZED MOVEMENTS DID NOT CONTRIBUTE TO THE PATIENT PASSING AWAY, THE CUSTOMER WAS ABLE TO MOVE THE BEAM MANUALLY. CODES ARE UPDATED TO REFLECT THE TABLE RELATED ISSUE.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THAT DURING A STEMI PROCEDURE, A CARDIAC ARREST OCCURRED. THE SYSTEM WAS IN USE FOR APPROXIMATELY ONE HOUR PRIOR TO ONSET OF THE CARDIAC ARREST. WHEN HOSPITAL STAFF INITIATED CPR, MOTORIZED MOVEMENTS OF THE SYSTEM WERE NOT AVAILABLE AND THE PATIENT TABLE COULD NOT BE LOWERED. THERE WAS NO DELAY IN DELIVERY OF CPR AND HOSPITAL STAFF USED STEP STOOLS TO ACHIEVE ENOUGH HEIGHT TO PERFORM CPR; HOWEVER, THE PATIENT PASSED AWAY. BASED ON THE INFORMATION RECEIVED, THE REPORTED INABILITY TO MOVE THE TABLE DID NOT CAUSE OR CONTRIBUTE TO THE CARDIAC ARREST. IT REMAINS UNKNOWN IF THE INABILITY TO MOVE THE TABLE CONTRIBUTED TO THE PATIENT OUTCOME IN ANY WAY. PHILIPS HAS INITIATED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1771592 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 M12 00884838099241

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Unknown Death