BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD

    MDR report key: 19296327 · Received May 13, 2024

    Report

    Report Number
    3003768277-2024-02727
    Event Type
    Malfunction
    Date Received
    May 13, 2024
    Date of Event
    May 7, 2024
    Report Date
    July 1, 2024
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838059054
    PMA / PMN Number
    K130638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. IT WAS REPORTED THAT THE SYSTEM WOULD NOT POWER ON. UPON TROUBLESHOOTING, PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE AND FOUND THE POTENTIAL PDU CONTROLLER WAS BAD AND, F10 IN MPDU WAS BLOWN. THE DEFECTIVE MPD CONTROL UNIT WAS RETURNED FOR FAILURE ANALYSIS AND CONFIRMED THE TRANSFORMER RESISTANCE BETWEEN PIN 1 AND 2 WAS 2.7 OHM AND WHICH SHOULD BE IN BETWEEN 140-155 OHM. FSE REPLACED THE MPDU CONTROL MODULE. AFTER THE REPLACEMENT OF MPDU CONTROL 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 WAS REPORTED TO PHILIPS THAT SYSTEM WOULD NOT POWER ON. THE DEVICE WAS OUTSIDE CLINICAL USE AT THE TIME OF REPORTED EVENT. NO HARM WAS REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438799 ALLURA XPER FD INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD20 00884838059054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown