BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMMETT

    MDR report key: 6025423 · Received October 11, 2016

    Report

    Report Number
    MW5065353
    Event Type
    Malfunction
    Date Received
    October 11, 2016
    Date of Event
    September 13, 2016
    Report Date
    October 11, 2016
    Manufacturer
    PHYSIO CONTROL
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    THE LIFEPAK 12 (EMMETT) (B)(4) WOULD NOT READ A TRACING WITH THE FOUR LEAD AND TWELVE READ ATTACHED TO THE PT. THE PROBLEM WAS INTERMITTENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670982 EMMETT LIFEPAK 12 MKJ PHYSIO CONTROL CE8327

    Patients

    Seq Age Sex Outcome Treatment
    1 Other