BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX-EMX DEFIBRILLATOR

    MDR report key: 2011661 · Received February 14, 2011

    Report

    Report Number
    1218950-2011-00389
    Event Type
    Malfunction
    Date Received
    February 14, 2011
    Report Date
    January 15, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE PADS/PADDLES ECG TEST FAILED. THERE WAS NO PT INVOLVEMENT. PHILIPS EVALUATED THE DEVICE AND VERIFIED THE FAILURE. THE POWER PCA WAS REPLACED TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PADS/PADDLES ECG TEST FAILED. THERE WAS NO PT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1