BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTART MRX-EMS DEFIBRILLATOR

    MDR report key: 1981151 · Received February 3, 2011

    Report

    Report Number
    1218950-2011-00306
    Event Type
    Death
    Date Received
    February 3, 2011
    Date of Event
    December 30, 2010
    Report Date
    January 6, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THEY COULD NOT GET AN ACCURATE ETCO2 WAVEFORM DURING A CODE. THE INVOLVED PT DIED, BUT THE CUSTOMER STATED THAT DEVICE BEHAVIOR WAS NOT A FACTOR IN PT OUTCOME. A F/U REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFO ABOUT THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY COULD NOT GET AN ACCURATE ETCO2 WAVEFORM DURING A CODE. THE INVOLVED PT DIED, BUT THE CUSTOMER STATED THAT DEVICE BEHAVIOR WAS NOT A FACTOR IN PT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART MRX-EMS DEFIBRILLATOR MKJ PHILIPS HEALTHCARE M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1