BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOCAP 5

    MDR report key: 1023569 · Received April 2, 2008

    Report

    Report Number
    9610105-2008-00014
    Event Type
    Malfunction
    Date Received
    April 2, 2008
    Date of Event
    March 11, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CARDIOCAP 5 ALLEGEDLY MADE AN EXPLOSIVE SOUND AND EMITTED SMOKE. NO PT INJURY WAS 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 17 YR