BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAM 450

    MDR report key: 3890643 · Received June 2, 2014

    Report

    Report Number
    2124823-2014-00012
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    GE HEALTHCARE
    Product Code
    MHX
    PMA / PMN Number
    K011000
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT REFLECTS PT 1 OF 3. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE BP1 WAS NOT FUNCTIONING AND THREE PTS WERE TREATED FOR HYPERTENSION THOUGH THEIR BLOOD PRESSURE WAS NOT ELEVATED. NO FURTHER INFO AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321842 TRAM 450 PHYSIOLOGICAL PT MONITOR MHX GE HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other