BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD

    MDR report key: 13117520 · Received December 30, 2021

    Report

    Report Number
    3003768277-2021-10296
    Event Type
    Malfunction
    Date Received
    December 30, 2021
    Date of Event
    August 25, 2021
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838054189
    PMA / PMN Number
    K162859
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS ENGINEER WENT ON-SITE AND RE-ESTABLISHED THE CONNECTION BETWEEN THE WIRELESS FOOTSWITCH AND THE BASE STATION. PHILIPS HAS CONFIRMED THAT THE REPORTED FAILURE IS DUE TO A CONNECTIVITY ISSUE. DUE TO A FIRMWARE BUG, THE WIRELESS FOOT SWITCH 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).

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THAT THE WIRELESS FOOTSWITCH LOST CONNECTION WITH THE BASE STATION. THE WIRELESS INDICATOR LED ON THE WIRELESS FOOTSWITCH WAS RED. THE SYSTEM WAS NOT IN CLINICAL USE WHEN THE ISSUE WAS IDENTIFIED. NO HARM HAS BEEN REPORTED TO PHILIPS. THE CUSTOMER STARTED USING THE WIRED FOOTSWITCH INSTEAD OF THE WIRELESS FOOTSWITCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2017622 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 Unknown