BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 17789903 · Received September 21, 2023

    Report

    Report Number
    3003768277-2023-05242
    Event Type
    Malfunction
    Date Received
    September 21, 2023
    Date of Event
    August 30, 2023
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838099258
    PMA / PMN Number
    K200917
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. THE PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE AND CONFIRMED THAT THE SYSTEM WAS NOT GETTING ON. REVIEW OF THE LOG FILES CONFIRMED THE REPORTED ISSUE. IT WAS IDENTIFIED THAT THE ISSUE OCCURRED SINCE THERE WAS NO POWER TO THE SYSTEM. THE FSE CHECKED THE SYSTEM AND FOUND THAT THE MIM & NYI FUSES WERE GOOD AND THE ISSUE WAS DUE TO THE DEFECTIVE PDU (POWER DISTRIBUTION UNIT) FAN TRAY AND DCPS (DIRECT CURRENT POWER SUPPLIES). THE FSE REPLACED THE DEFECTIVE PDU FAN TRAY AND DCPS ASSEMBLY TO RESOLVE THE REPORTED ISSUE. AFTER THE REPLACEMENT, THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THAT THE SYSTEM DID NOT POWER ON SUCCESSFULLY. THE ISSUE WAS FOUND OUTSIDE OF CLINICAL USE. NO HARM HAS BEEN REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1446581 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 M20 00884838099258

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown