BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD

    MDR report key: 17697088 · Received September 7, 2023

    Report

    Report Number
    3003768277-2023-04844
    Event Type
    Malfunction
    Date Received
    September 7, 2023
    Date of Event
    August 8, 2023
    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. THE PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE AND CONFIRMED THAT SYSTEM WAS NOT BOOTING UP. REVIEW OF THE LOG FILES CONFIRMED THE ISSUE WITH THE FLEXVISION PC. THE FSE PERFORMED SYSTEM TROUBLESHOOTING AND IDENTIFIED THAT THE FLEXVISION PC WAS NOT WORKING. THE FSE REPLACED THE FLEXVISION PC TO RESOLVE THE ISSUE. LATER, THE RGB MEDIAWALL IN THE TSM (TOUCH SCREEN MODULE) WAS FOUND DEFECTIVE. SO, THE FSE REPLACED THE RGB MEDIAWALL TO FIX THE DISPLAY BUTTON ISSUE IN THE TSM MODULE. 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 ALLURA SYSTEM DID NOT BOOT UP SUCCESSFULLY AS THE START-UP COUNTDOWN GOT STUCK AT 00:00. THE SYSTEM WAS NOT IN CLINICAL USE. THERE WAS NO REPORTED PATIENT OR USER HARM. A PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE AND REPLACED THE FLEXVISION PC AND THE RGB MEDIAWALL 2900 WHICH RETURNED THE DEVICE TO USE IN GOOD WORKING ORDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1038491 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 Unknown