BEUDAMED
    FDA Adverse Event Death Summary report: N

    INFORMATION CENTER NETWORK DATABASE

    MDR report key: 3213230 · Received July 1, 2013

    Report

    Report Number
    1218950-2013-02751
    Event Type
    Death
    Date Received
    July 1, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 26, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K011093
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): A FOLLOW UP REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFORMATION CONCERNING THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY WERE EXPERIENCING DROPOUTS WITH A TELEMETRY DEVICE. THE PATIENT EXPIRED. THERE IS NO ALLEGATION OF DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297788 INFORMATION CENTER NETWORK DATABASE MHX, DRT MHX PHILIPS MEDICAL SYSTEMS 865011 (M3155)

    Patients

    Seq Age Sex Outcome Treatment
    1