BEUDAMED
    FDA Adverse Event Death Summary report: N

    AZURION 3 M15

    MDR report key: 10430758 · Received August 20, 2020

    Report

    Report Number
    3003768251-2020-00004
    Event Type
    Death
    Date Received
    August 20, 2020
    Date of Event
    August 8, 2020
    Report Date
    August 10, 2020
    Manufacturer
    PHILIPS MEDICAL SYSTEMS DMC GMBH
    Product Code
    OWB
    UDI-DI
    00884838085282
    PMA / PMN Number
    K172822
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. A PHILIPS FIELD SERVICE ENGINEER INSPECTED THE AZURION SYSTEM ON SITE AND CONFIRMED, THAT THERE WAS NO MALFUNCTION. BUT DETERMINED, THAT THE UNINTERRUPTIBLE POWER SUPPLY (UPS) MANUFACTURED BY VERTIV, WHICH WAS CONNECTED TO THE AZURION SYSTEM, WAS NOT FUNCTIONING PROPERLY. A VERTIV REPRESENTATIVE WAS DISPATCHED, WHO RECALIBRATED THE UPS. BASED ON THE INFORMATION COLLECTED AND INVESTIGATION PERFORMED, PHILIPS CANNOT CONFIRM IF THE REPORTED PROBLEM HAD ANY CONTRIBUTION TO THE OUTCOME OF THE PATIENT. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    WHEN THE INVESTIGATION HAS BEEN COMPLETED PHILIPS WILL INFORM THE FDA.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, THE AZURION SYSTEM SHUT DOWN BECAUSE OF LOSS OF POWER. THE INVOLVED PATIENT PASSED AWAY. PHILIPS HAS STARTED AN INVESTIGATION FOR THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894743 AZURION 3 M15 INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS DMC GMBH 722064 00884838085282

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death