BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD

    MDR report key: 17697986 · Received September 7, 2023

    Report

    Report Number
    3003768277-2023-04860
    Event Type
    Malfunction
    Date Received
    September 7, 2023
    Date of Event
    August 23, 2023
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838054202
    PMA / PMN Number
    K162859
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE INFORMATION COLLECTED, THE SYSTEM WAS OUTSIDE CLINICAL USE AT THE TIME OF THE EVENT. THE PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE AND CONFIRMED THAT THE X-RAY IS NOT POSSIBLE. REVIEW OF THE LOG FILE SHOWED THAT FDC POST FAILED AND FDC R1 LED WAS RED. DURING TROUBLESHOOTING, FSE FOUND THAT ISSUE WAS WITH FDC. FSE REPLACED FDC. AFTER REPLACEMENT SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THAT EXPOSURE WAS NOT POSSIBLE. THE SYSTEM WAS IN CLINICAL USE. THERE WAS NO REPORTED PATIENT OR USER HARM. A PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ON-SITE AND CONFIRMED THE REPORTED PROBLEM. TROUBLESHOOTING ACTIONS SHOWED A PROBLEM WITH THE FLAT DETECTOR CONTROLLER (FDC). THE FSE REPLACED THE FDC AND RETURNED THE SYSTEM TO USE IN GOOD WORKING ORDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2089947 ALLURA XPER FD INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD20 00884838054202

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown