BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 4230961 · Received October 15, 2014

    Report

    Report Number
    1218950-2014-06195
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Report Date
    September 29, 2014
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PR#: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE ETCO2 WAS BROKEN. THE CUSTOMER NOTED NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652824 HEARTSTART MRX - EMS DEFIBRILLATOR MKJ M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1