BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 2231216 · Received July 22, 2011

    Report

    Report Number
    1218950-2011-02092
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Report Date
    June 30, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED A PROBLEM WITH THE THERAPY KNOB. THE CUSTOMER CONFIRMED THAT THERE WAS NO PT INVOLVEMENT. THE DEVICE WAS EVALUATED BY PHILIPS. THE SYMPTOM WAS CLARIFIED AS THE ENERGY SELECT SWITCH INTERMITTENTLY NOT WORKING. THE ENERGY SELECT SWITCH WAS REPLACED TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A PROBLEM WITH THE THERAPY KNOB. THE CUSTOMER CONFIRMED THAT THERE WAS NO PT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1