BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD

    MDR report key: 18789387 · Received February 27, 2024

    Report

    Report Number
    3003768277-2024-01340
    Event Type
    Malfunction
    Date Received
    February 27, 2024
    Date of Event
    February 12, 2024
    Report Date
    March 10, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    IZI
    UDI-DI
    00884838059061
    PMA / PMN Number
    K130842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE ADDITIONAL INFORMATION COLLECTED, THE SYSTEM WAS NOT IN CLINICAL USE AT THE TIME THE EVENT OCCURRED. THE PHILIPS REMOTE SERVICE ENGINEER (RSE) CONNECTED WITH THE CUSTOMER REMOTELY AND FOUND THAT SYSTEM WAS NOT BOOTING UP. AFTER REVIEWING LOG FILE, RSE FOUND THE SYSTEM REPORTED FLEX VISION MONITORING FAILED AND IT NOT CONNECTED TO RGB MEDIA WALL. RSE HAS RESTARTED THE SYSTEM SEVERAL TIMES AND DISCONNECTED POWER TO THE BREAKER; HOWEVER, THE PROBLEM PERSISTS. UPON INSPECTION OF THE B CABINET, RSE CONFIRMED THAT THE ISSUE HAS BEEN TRACED TO THE RGB MEDIA WALL. TO RESOLVE THE ISSUE RSE ASKED THE CUSTOMER REPLACED THE RGB MEDIA WALL. AFTER REPLACEMENT OF THE RGB MEDIA WALL, THE SYSTEM 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 SYSTEM WOULD NOT BOOT UP. IT WOULD FREEZE AT 0:00. THE SYSTEM USE AT THE TIME OF EVENT WAS NOT IN CLINICAL USE. THERE WAS NO HARM REPORTED. A PHILIPS FIELD SERVICE ENGINEER REPLACED THE RBG MEDIA WALL, AND RETURNED THE SYSTEM TO USE IN A GOOD WORKING CONDITION. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111120 ALLURA XPER FD SYSTEM, X-RAY, ANGIOGRAPHIC IZI PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD20 BIPLANE 00884838059061

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown