BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX-EMS DEFIBRILLATOR

    MDR report key: 2220164 · Received August 11, 2011

    Report

    Report Number
    1218950-2011-02328
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Report Date
    July 14, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THEY INSTALLED NEW BATTERY AND UNIT SHUT DOWN. THERE WAS NO REPORT OF PT INVOLVEMENT. A THIRD PARTY REPAIR SERVICE TECHNICIAN WENT TO THE CUSTOMER SIT AND COULD NOT RECREATE THE REPORTED FAILURE. ALL PERFORMANCE ASSURANCE TESTING PASSED. THE UNIT REMAINS AT THE CUSTOMER SITE. DUE TO NOT BEING ABLE TO RECREATE THE REPORTED FAILURE WE CAN NOT DETERMINE THE CAUSE OF THIS REPORTED ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY INSTALLED NEW BATTERY AND UNIT SHUT DOWN. THERE WAS NO REPORT OF PT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1