BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD20/10 & ALLURA XPER FD20/20

    MDR report key: 16188266 · Received January 17, 2023

    Report

    Report Number
    3003768277-2023-00336
    Event Type
    Malfunction
    Date Received
    January 17, 2023
    Date of Event
    January 6, 2023
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    PMA / PMN Number
    K033737
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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 TURNING ON. UPON INSPECTION, FSE DETERMINED THAT THE RGB MODULE WAS FAULTY. THE FSE REPLACED THE RGB MODULE. AFTER REPLACEMENT OF THE RGB MODULE, 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 EQUIPMENT DOES NOT TURN ON. THE DEVICE WAS NOT IN CLINICAL USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81079 ALLURA XPER FD20/10 & ALLURA XPER FD20/20 INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD20/10 & FD20/20

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown