BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRO COMPUTED TOMOGRAPHY (CT) X

    MDR report key: 17452484 · Received August 2, 2023

    Report

    Report Number
    MW5120532
    Event Type
    Malfunction
    Date Received
    August 2, 2023
    Date of Event
    June 19, 2023
    Report Date
    August 1, 2023
    Manufacturer
    MOBIUS IMAGING LLC.
    Product Code
    JAK
    UDI-DI
    00869346000200
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    003
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    MACHINE WAS WARMED UP AND THE BED WAS FUNCTIONING. PATIENT WAS PUT TO SLEEP AND POSITIONED ON THE AIRO TABLE. HIP PINS WERE PLACED, CT WAS CALLED FOR THE SPIN. THE SCOUT WAS TAKEN FOLLOWED BY THE SCAN. AFTER THE SCAN WAS TAKEN, THE IMAGES WOULD NOT SEND AND THE AIRO JUST KEPT SPINNING AND SHUT OFF. STRYKER NAVIGATION REP CALLED THE AIRO REP AND WAS INSTRUCTED TO CALL THE STRYKER AIRO SUPPORT NUMBER. TROUBLE SHOOTING WAS UNSUCCESSFUL. CASE WAS CANCELED. NO INCISION WAS MADE. PATIENT WAS EXTUBATED AND SENT TO PACU. UPON INVESTIGATION FOUND BATTERY NUMBER 2 TO BE INOPERATIVE. THE DEVICE HAS A CONTROL PANEL WHICH INDICATES "POWER" AND "BATTERY CHARGING" ON THE LOWER LEFT OF THE SCREEN BUT IT CANNOT TELL THE CHARGE CAPACITY OF THE INDIVIDUAL BATTERIES TO KNOW THAT THEY WILL RETAIN THE CHARGE WHEN IT IS UNPLUGGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773196 AIRO COMPUTED TOMOGRAPHY (CT) X SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK MOBIUS IMAGING LLC. MOBICT-32 00869346000200

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Male Other