BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD

    MDR report key: 15759179 · Received November 9, 2022

    Report

    Report Number
    3003768277-2022-00840
    Event Type
    Malfunction
    Date Received
    November 9, 2022
    Date of Event
    October 10, 2022
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    IZI
    UDI-DI
    00884838059030
    PMA / PMN Number
    K130842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE ADDITIONAL INFORMATION COLLECTED, THE SYSTEM WAS IN CLINICAL USE WHEN THE ISSUE WAS IDENTIFIED. PHILIPS REMOTE SERVICE ENGINEER (RSE) CONFIRMED THAT THE SYSTEM FAILED TO START. FURTHER, FIELD SERVICE ENGINEER (FSE) WENT ON-SITE, AND FOUND DEVICE CANNOT ENTER SYSTEM. FSE SWITCHED THE POWER MODULE OF IPPC AND HOST PC, BUT THE PROBLEM PERSISTED, FSE CONFIRMED THAT IT WAS HOST PC MAIN BOARD THAT WAS DEFECTIVE. FSE REPLACED HOST PC. AFTER 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 HOST PC WOULD NOT BOOT UP. THERE WAS NO REPORT OF HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2328995 ALLURA XPER FD SYSTEM X-RAY ANGIOGRAPHIC IZI PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD10 00884838059030

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown