BEUDAMED
    FDA Adverse Event No answer provided Summary report: N

    HAMILTON

    MDR report key: 11220282 · Received January 23, 2021

    Report

    Report Number
    0002937708-2021-00009
    Event Type
    No answer provided
    Date Received
    January 23, 2021
    Date of Event
    April 1, 2020
    Report Date
    August 15, 2022
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800761
    Report Source
    Distributor report
    Reporter Location
    NV, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS INTUBATED AND MECHANICALLY VENTILATED WITH THE MR1 SAFE VENTILATOR, THE HAMILTON MR 1. AT THE END OF THE SCAN AS THE PATIENT WAS BEING ROLLED OUT OF THE MRI SUITE, THE VENTILATOR CAME TOO CLOSE TO THE MAGNET AND THE VENTILATOR SHUT DOWN. THE SCREEN OF THE VENT WENT BLANK, THE ALARM SOUNDED AND ITS LIGHTS FLASHED. PT WAS REMOVED FROM THE VENT AND MANUALLY VENTILATED. PATIENT DID NOT SUFFER DELETERIOUS EFFECTS. THE VENT WAS SHUT OFF AND THEN RESTARTED AWAY FROM THE MAGNET. IT POWERED BACK ON AND WAS ABLE TO FUNCTION NORMALLY. THE PATIENT WAS PLACED BACK ON THE VENT AND SAFELY TRANSPORTED TO UNIT.

    Description of Event or Problem · 1

    PATIENT WAS INTUBATED AND MECHANICALLY VENTILATED WITH THE MR1 SAFE VENTILATOR, THE HAMILTON MR 1. AT THE END OF THE SCAN AS THE PATIENT WAS BEING ROLLED OUT OF THE MRI SUITE, THE VENTILATOR CAME TOO CLOSE TO THE MAGNET AND THE VENTILATOR SHUT DOWN. THE SCREEN OF THE VENT WENT BLANK, THE ALARM SOUNDED AND ITS LIGHTS FLASHED. PT WAS REMOVED FROM THE VENT AND MANUALLY VENTILATED. PATIENT DID NOT SUFFER DELETERIOUS EFFECTS. THE VENT WAS SHUT OFF AND THEN RESTARTED AWAY FROM THE MAGNET. IT POWERED BACK ON AND WAS ABLE TO FUNCTION NORMALLY. THE PATIENT WAS PLACED BACK ON THE VENT AND SAFELY TRANSPORTED TO UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116642 HAMILTON HAMILTON-MR1 CBK HAMILTON MEDICAL AG 161010 07630002800761

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown