BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 11906590 · Received May 31, 2021

    Report

    Report Number
    3003768277-2021-10022
    Event Type
    Malfunction
    Date Received
    May 31, 2021
    Date of Event
    May 2, 2021
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838085268
    PMA / PMN Number
    K163715
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: UPDATED PATIENT OUTCOME CODE FROM (B)(6). ADDITIONAL MANUFACTURER NARRATIVE- PHILIPS HAS INVESTIGATED THIS COMPLAINT. PHILIPS HAS PERFORMED A GOOD FAITH EFFORT TO GET FURTHER INFORMATION REGARDING THE CLINICAL STATUS OF THE PATIENT. HOWEVER, THE CUSTOMER DECLINED TO PROVIDE ADDITIONAL INFORMATION. PHILIPS HAS ANALYZED THE LOG FILE AND FOUND THAT THE SYSTEM IDENTIFIED COLLISIONS WHILE THE USER WAS PERFORMING MOTORIZED FRONTAL STAND MOVEMENT. THE COLLISION ERRORS STOPPED THE C-ARM MOVEMENT AND WERE CAUSED BY MOTOR CURRENT VALUES BEING OUT OF TOLERANCE, NOT PHYSICAL COLLISIONS. A PHILIPS ENGINEER RECALIBRATED THE MOTOR CURRENTS AND THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT WHILE ATTEMPTING TO PERFORM A COMPLETION ANGIOGRAM DURING AN EMERGENCY VASCULAR SURGICAL BYPASS PROCEDURE, THE PHILIPS AZURION SYSTEM STOPPED RESPONDING TO MOTION CONTROLS. THE DETECTOR WAS STUCK IN A POSITION THAT DID NOT ALLOW APPROPRIATE ACCESS TO THE PATIENT. DUE TO THE CONDITION OF THE PATIENT (ELDERLY PATIENT WITH MULTIPLE SIGNIFICANT CARDIOVASCULAR, PULMONARY AND OTHER CONDITIONS PRESENTING A HIGH ANESTHESIA RISK), THE SURGEON DECIDED TO END THE CASE EVEN THOUGH THERE WAS INSUFFICIENT INFORMATION TO EVALUATE THE SUCCESS OF THE PROCEDURE AND WHETHER ADDITIONAL STEPS COULD BE PERFORMED DURING THIS OPERATION TO ENSURE ADEQUATE PERFUSION OF THE LIMB. THE HIGH-RISK PATIENT REQUIRED REOPERATION TWO DAYS LATER TO ADDRESS LIMB-THREATENING ISSUES THAT ACCORDING TO THE SURGEON WOULD HAVE BEEN PREVIOUSLY DETECTED AND ADDRESSED HAD THE SYSTEM NOT FAILED IN THE MIDDLE OF THE COMPLETION ANGIOGRAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803005 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 M20 00884838085268

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention