BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAM 451N

    MDR report key: 5094386 · Received September 22, 2015

    Report

    Report Number
    2124823-2015-00023
    Event Type
    Malfunction
    Date Received
    September 22, 2015
    Report Date
    April 20, 2015
    Manufacturer
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
    Product Code
    MHX
    PMA / PMN Number
    K053121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE WAS IDENTIFIED TO BE A FAILED TRAM DAS MODULE BASED ON THE SERVICE INFORMATION PROVIDED BY THE FIELD ENGINEER. THE TRAM DAS MODULE WAS REPLACED TO CORRECT THE REPORTED ISSUE. FURTHER INVESTIGATION INTO THE ROOT CAUSE COULD NOT BE COMPLETED SINCE THE FAILED DAS MODULE WAS DISPOSED OF.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION COULD NOT BE OBTAINED DUE TO COUNTRY PRIVACY LAWS. INCIDENT DATE IS UNKNOWN. THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S., AND THEREFORE THIS INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE TRAM DEVICE PROVIDED AN INACCURATE LOW INVASIVE BLOOD PRESSURE. NO PATIENT COMPROMISE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625802 TRAM 451N PHYSIOLOGICAL PATIENT MONITOR MHX GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. MODULO TRAM CON TEC SBB11170695GA

    Patients

    Seq Age Sex Outcome Treatment
    1