BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD

    MDR report key: 20198490 · Received September 12, 2024

    Report

    Report Number
    3003768277-2024-05082
    Event Type
    Malfunction
    Date Received
    September 12, 2024
    Date of Event
    August 27, 2024
    Report Date
    November 15, 2024
    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
    KS, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE ADDITIONAL INFORMATION COLLECTED, A CARDIOVASCULAR DIAGNOSTIC PROCEDURE WAS PERFORMED WHEN THE ISSUE HAPPENED. THE PROCEDURE WAS DELAYED AND COMPLETED BY USING HAND SWITCH IN THE CONTROL ROOM. A FIELD SERVICE ENGINEER (FSE) VISITED ONSITE AND FOUND THAT WIRED FOOTSWITCH WAS UNABLE TO MAKE FLUOROSCOPY. UPON TROUBLESHOOTING FSE FOUND THAT THE FOOTSWITCH DID NOT WORK AS INTENDED. THE CAUSE OF THE FOOTSWITCH FAILED COULD NOT BE DETERMINED BY THE SUPPLIER'S PART ANALYSIS. TO RESOLVE THE ISSUE, FSE REPLACED WIRED FOOTSWITCH. AFTER REPLACEMENT WIRED FOOTSWITCH, THE SYSTEM WAS WORKING AS INTENDED. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT WIRED FOOTSWITCH WAS UNABLE TO MAKE FLUORO OR ACQUISITION. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT. NO HARM TO THE PATIENT OR USER WAS REPORTED. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1473637 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 NA Unknown