BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD

    MDR report key: 12567004 · Received October 4, 2021

    Report

    Report Number
    3003768277-2021-10157
    Event Type
    Malfunction
    Date Received
    October 4, 2021
    Date of Event
    September 7, 2021
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838054219
    PMA / PMN Number
    K162859
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDTL NARRATIVE: PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE INFORMATION COLLECTED, THE WIRELESS FOOTSWITCH LOST ITS CONNECTION. THIS PROBLEM WAS DISCOVERED OUTSIDE OF CLINICAL USE. THE PHILIPS SERVICE ENGINEER REPLACED THE BASE STATION AND RECONNECTED THE WIRELESS FOOTSWITCH WHICH SOLVED THE PROBLEM. 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). CORRECTED DATA: UPDATED CODES BASED ON INVESTIGATION.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO PHILIPS THAT THE WIRELESS FOOTSWITCH INTERMITTENTLY LOST CONNECTION. NO HARM HAS BEEN REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1469525 ALLURA XPER FD IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD20/10 00884838054219

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown