BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 2023077 · Received February 15, 2011

    Report

    Report Number
    1218950-2011-00414
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Report Date
    January 20, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    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): IT WAS REPORTED THAT THE CHARGE BUTTON STUCK. THE DEVICE WAS EVALUATED AT PHILIPS. THE SYMPTOM WAS CLARIFIED AS THE DEVICE HANGING WHEN CHARGE BUTTON PRESSED DURING OPCHECK. THE THERAPY PCA WAS REPLACED TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CHARGE BUTTON STUCK.

    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