BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BODYTOM

    MDR report key: 12872334 · Received November 24, 2021

    Report

    Report Number
    3004938766-2021-00018
    Event Type
    Malfunction
    Date Received
    November 24, 2021
    Date of Event
    October 26, 2019
    Report Date
    November 24, 2021
    Manufacturer
    NEUROLOGICA CORPORATION
    Product Code
    JAK
    PMA / PMN Number
    K102677
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE OF THE INCIDENT WAS FOUND TO BE RELATED TO THE CONTROL SOFTWARE, WHICH STOPPED RESPONDING. NEUROLOGICA IS STILL CONDUCTING AN INVESTIGATION TO DETERMINE THE EXACT REASON FOR THIS INCIDENT. AFTER REVIEW OF THE DEVICE HISTORY LOGS, IT HAS BEEN CONFIRMED THAT X-RAY WAS NOT FIRING EVEN THOUGH THE X-RAY LIGHT WAS SHOWING AS ON. NO HARM TO THE PATIENT OR USER WAS STATED, AS THERE WAS NO X-RAY FIRING SO NO RADIATION WAS RECEIVED. THE FIELD SERVICE REPRESENTATIVE CONFIRMED THE DEVICE TO BE FUNCTIONING PROPERLY, AS WELL AS THE BURNING SMELL WAS GONE. THE LIKELIHOOD OF PATIENT/USER INJURY IS NEGLIGIBLE CURRENTLY. FUTURE SERVICE CALLS WILL BE MONITORED FOR SIMILAR INCIDENTS IN THE FIELD.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT WHILE PERFORMING AN AIR CALIBRATION, THE COMPUTED TOMOGRAPHY (CT) SYSTEM STARTED TO FIRE CONTINUOUSLY WITHOUT STOPPING. THE CUSTOMER TRIED TO PRESS THE EMERGENCY STOP BUTTON TO HALT ALL DEVICE ACTIONS, HOWEVER, THAT DID NOT SEEM TO WORK. THE DEVICE EVENTUALLY TURNED OFF AFTER THE USER ATTEMPTED TO PRESS THE ON/OFF BUTTON AGAIN. THE CUSTOMER CLAIMED THEY COULD SMELL A BURNING SMELL FROM THE SCANNER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1768337 BODYTOM COMPUTED TOMOGRAPHY X-RAY SYSTEM JAK NEUROLOGICA CORPORATION NL4000

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown