BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 1913724 · Received November 23, 2010

    Report

    Report Number
    1218950-2010-02355
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Report Date
    October 28, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED AN INTERMITTENT CONNECTION WITH INTERNAL PADDLES. THE UNIT WAS EVALUATED AT PHILIPS. THE SYMPTOM COULD NOT BE DUPLICATED. NO RELATED PARTS WERE REPLACED. THE DEVICE WAS RETURNED TO THE CUSTOMER AFTER PASSING ALL TESTING. WE ARE CONSIDERING THIS A MALFUNCTION. WE CANNOT DETERMINE THE CAUSE, SINCE THE SYMPTOM COULD NOT BE DUPLICATED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN INTERMITTENT CONNECTION WITH INTERNAL PADDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART MRX MKJ PHILIPS HEALTHCARE M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1