BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 6054793 · Received October 25, 2016

    Report

    Report Number
    1218950-2016-06711
    Event Type
    Malfunction
    Date Received
    October 25, 2016
    Report Date
    September 30, 2016
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE KEYPAD WAS NOT FUNCTIONING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706109 HEART START XL DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M4735A NA

    Patients

    Seq Age Sex Outcome Treatment
    1