BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRACEMASTER ECG MANAGEMENT SYSTEM

    MDR report key: 2389984 · Received December 20, 2011

    Report

    Report Number
    1218950-2011-03986
    Event Type
    Death
    Date Received
    December 20, 2011
    Report Date
    December 12, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSH
    PMA / PMN Number
    K032103
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE USER WAS UNABLE TO ACCESS AN ECG FOR DIAGNOSIS. THE INVOLVED PT DIED. WE HAVE REQUESTED ADD'L INFO. THIS COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFO ABOUT THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE USER WAS UNABLE TO ACCESS AN ECG FOR DIAGNOSIS. THE INVOLVED PT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRACEMASTER ECG MANAGEMENT SYSTEM DSH PHILIPS MEDICAL SYSTEMS 860281

    Patients

    Seq Age Sex Outcome Treatment
    1 Death