BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAC 5500

    MDR report key: 5459878 · Received February 25, 2016

    Report

    Report Number
    5459878
    Event Type
    Malfunction
    Date Received
    February 25, 2016
    Date of Event
    February 9, 2016
    Report Date
    February 23, 2016
    Manufacturer
    GE MEDICAL INFORMATION TECHNOLOGIES, INC.
    Product Code
    DPS
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER THE PATIENT WAS SUCCESSFULLY RESUSCITATED, A STAT EKG WAS ORDERED DUE TO CARDIAC ARREST. THE EKG MACHINE DID NOT FUNCTION AND ALERTED UNABLE TO CONNECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118214 MAC 5500 ELECTROCARDIOGRAPH DPS GE MEDICAL INFORMATION TECHNOLOGIES, INC. MAC 5500

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR