BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 2212828 · Received July 12, 2011

    Report

    Report Number
    1218950-2011-01977
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Report Date
    June 15, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE UNIT WOULD POWER ON BY ITSELF. THERE WAS NO REPORT OF PT INVOLVEMENT. THE UNIT WAS EVALUATED BY PHILIPS AND THE FAILURE WAS CONFIRMED. THE UNIT WOULD ALSO POWER OFF IF THE SWITCH WERE TOUCHED. REPLACEMENT OF THE THERAPY SWITCH RESOLVED THIS FAILURE. THE UNIT PASSED ALL TESTING AND WAS SHIPPED BACK TO THE CUSTOMER SITE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT WOULD POWER ON BY ITSELF. 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