BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 6076611 · Received November 3, 2016

    Report

    Report Number
    1218950-2016-06918
    Event Type
    Malfunction
    Date Received
    November 3, 2016
    Report Date
    October 10, 2016
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE HAS INTERMITTENT NOISE ON SCREEN. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728837 HEART START XL DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1