BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOCAP 5

    MDR report key: 1023571 · Received April 2, 2008

    Report

    Report Number
    9610105-2008-00013
    Event Type
    Malfunction
    Date Received
    April 2, 2008
    Date of Event
    March 12, 2008
    Report Date
    April 1, 2008
    Manufacturer
    GE HEALTHCARE FINLAND OY
    Product Code
    MHX
    PMA / PMN Number
    K012387
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE MONITOR EMITTED SMOKE WHEN IT WAS TURNED ON IN THE MORNING. NO PT WAS CONNECTED TO THE DEVICE AND HENSE NO INJURY REPORTED. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOCAP 5 PHYSIOLOGIC PATIENT MONITOR MHX GE HEALTHCARE FINLAND OY

    Patients

    Seq Age Sex Outcome Treatment
    1