BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 1883974 · Received October 21, 2010

    Report

    Report Number
    1218950-2010-02002
    Event Type
    Malfunction
    Date Received
    October 21, 2010
    Report Date
    September 21, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THERE WAS AN INTERMITTENT POWER ISSUE. THE UNIT WAS EVALUATED AT PHILIPS, BUT THE REPORTED SYMPTOM COULD NOT BE RECREATED. BASED ON THE CUSTOMER'S REPORT, WE ARE CONSIDERING THIS A MALFUNCTION. WE CAN NOT DETERMINE THE CAUSE, SINCE THE SYMPTOM WAS NOT DUPLICATED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS AN INTERMITTENT POWER ISSUE.

    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