BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLURA XPER FD

    MDR report key: 12091633 · Received June 30, 2021

    Report

    Report Number
    3003768277-2021-10031
    Event Type
    Injury
    Date Received
    June 30, 2021
    Date of Event
    June 8, 2021
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838054189
    PMA / PMN Number
    K130638
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: BECOME AWARE DATE AND CODES ADD. MANUFACTURE NARRATIVE: PHILIPS HAS INVESTIGATED THIS COMPLAINT. A PHILIPS SERVICE ENGINEER INSPECTED THE SYSTEM ON SITE AND REPLACED THE WIRELESS FOOTSWITCH AND THE WIRELESS FOOTSWITCH BASE STATION. THE ENGINEER ALSO CONNECTED THE WIRED FOOTSWITCH AND INFORMED THE USER TO USE THE WIRED FOOTSWITCH IN CASE OF PROBLEMS WITH THE WIRELESS FOOTSWITCH. PHILIPS ANALYZED THE REPLACED WIRELESS FOOTSWITCH AND BASE STATION AND CONFIRMED A CONNECTIVITY ISSUE. DUE TO A FIRMWARE BUG THE WIRELESS FOOTSWITCH CAN SUDDENLY STOP RESPONDING WHEN A NUMBER OF AMBIENT CONDITIONS COEXIST, SUCH AS EMC DISTURBANCE AND THE PRESENCE OF OTHER WIRELESS DEVICES IN THE ROOM. PHILIPS HAS INITIATED A MEDICAL DEVICE CORRECTION/FIELD SAFETY CORRECTIVE ACTION (2021-IGT-BST-020). THE PATIENT DEMOGRAPHICS HAVE NOT BEEN PROVIDED TO PHILIPS.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO PHILIPS THAT DURING AN ACUTE ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION PROCEDURE THE WIRELESS FOOTSWITCH STOPPED WORKING. THE PROCEDURE COULD NOT BE CONTINUED ON THE ALLURA SYSTEM AND THE PATIENT HAD TO BE TRANSFERRED TO ANOTHER ROOM. BEFORE MOVING THE PATIENT, THE CORONARY WIRE HAD TO BE REMOVED WITHOUT IMAGING. ACCORDING TO THE CUSTOMER THE RESTORATION OF BLOOD FLOW WAS DELAYED BY APPROXIMATELY 30 TO 50 MINUTES AND THE PATIENT REQUIRED A STENT TREATMENT OF A LONGER CORONARY SEGMENT. PHILIPS HAS STARTED AN INVESTIGATION OF THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    991375 ALLURA XPER FD INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD10 00884838054189

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R