BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE TELEMETRY SYSTEM

    MDR report key: 3221611 · Received July 1, 2013

    Report

    Report Number
    1218950-2013-02730
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Report Date
    April 8, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K041741
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY WERE EXPERIENCING DROPOUTS FROM THEIR MX40 DEVICE. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297381 INTELLIVUE TELEMETRY SYSTEM MHX PHILIPS MEDICAL SYSTEMS M4840A

    Patients

    Seq Age Sex Outcome Treatment
    1