BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSPORT MONITOR

    MDR report key: 250898 · Received November 18, 1999

    Report

    Report Number
    1218950-1999-00137
    Event Type
    Injury
    Date Received
    November 18, 1999
    Date of Event
    June 3, 1998
    Report Date
    October 20, 1999
    Manufacturer
    AGILENT TECHNOLOGIES, INC.
    Product Code
    MHX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE FOLLOWING EVENT TO AGILENT TECHNOLOGIES: PT WAS PLACED IN SCANNER BEING MONITORED BY THE M1275A TRANSPORT MONITOR ALONG WITH A VENTILATOR. SCANNER TESTS WERE COMPLETED. PT SEEMED TO BE OK DURING TESTS. HOWEVER, WHEN PT WAS TO BE REMOVED FROM SCANNER, HE WAS IN FULL CARDIAC ARREST. MONITOR AND VENTILATOR DID NOT ALARM VISUALLY AND AUDIBLY. ECG AND SP02 WERE TURNED ON. PT SUFFERED SEVERE BRAIN DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSPORT MONITOR TRANSPORT MONITOR MHX AGILENT TECHNOLOGIES, INC. M1275A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| L