BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 16188201 · Received January 17, 2023

    Report

    Report Number
    3003768277-2023-00335
    Event Type
    Malfunction
    Date Received
    January 17, 2023
    Date of Event
    January 9, 2023
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838099241
    PMA / PMN Number
    K200917
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 MACHINE IS NOT SWITCHING ON. REVIEW OF THE SYSTEM LOG FILE SHOWED THAT PDU FUSE AND OVER VOLTAGE BOARD IN PDU FOUND DEFECTIVE. THE FSE REPLACED THE PDU FUSE AND OVER VOLTAGE BOARD IN PDU. AFTER REPLACEMENT OF THE PDU FUSE AND OVER VOLTAGE BOARD IN PDU, THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME. EVALUATION METHOD CODE WAS CORRECTED.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THAT THE AZURION 7 M12 SYSTEM WAS NOT SWITCHING ON. NO HARM HAS BEEN REPORTED. PHILIPS HAS STARTED AN INVESTIGATION OF THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1225827 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 M12 00884838099241

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown