BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 2123540 · Received June 9, 2011

    Report

    Report Number
    1218950-2011-01654
    Event Type
    Malfunction
    Date Received
    June 9, 2011
    Report Date
    May 17, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED A FAILURE TO SHOCK. THERE WAS NO REPORT OF PT INVOLVEMENT. THE DEVICE WAS EVALUATED BY THE CUSTOMER'S BIOMED. THERE WERE CHARGE/SHOCK FAILURE/THERAPY PCA MESSAGES IN THE STATUS LOG. THE THERAPY PCA WAS REPLACED TO RESOLVE THE ISSUE. THE DEVICE PASSED ALL TESTING AND WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FAILURE TO SHOCK. 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 M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1