BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIRO CT SCANNER

    MDR report key: 15347426 · Received September 2, 2022

    Report

    Report Number
    3010151377-2022-00001
    Event Type
    Injury
    Date Received
    September 2, 2022
    Date of Event
    August 3, 2022
    Report Date
    November 14, 2022
    Manufacturer
    MOBIUS IMAGING, LLC
    Product Code
    JAK
    UDI-DI
    00869346000200
    PMA / PMN Number
    K131431
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE REMAINED IN FIELD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A CASE, THE AIRO TIPPED AND THE PATIENT SHIFTED OFF THE TABLE. THE PHYSICIAN'S ASSISTANT CAUGHT THE PATIENT'S HEAD AND DUE TO THE IMPACT FROM THE CATCH, THE PATIENT EXPERIENCED MILD LACERATIONS. THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY AND THE PATIENT WILL BE RESCHEDULED FOR SURGERY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A CASE, THE AIRO TIPPED AND THE PATIENT SHIFTED OFF THE TABLE. THE PHYSICIAN'S ASSISTANT CAUGHT THE PATIENT'S HEAD AND DUE TO THE IMPACT FROM THE CATCH, THE PATIENT EXPERIENCED MILD LACERATIONS. THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY AND THE PATIENT WILL BE RESCHEDULED FOR SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826660 AIRO CT SCANNER SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK MOBIUS IMAGING, LLC MOBICT-32 00869346000200

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other