BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTREAM XL

    MDR report key: 1232068 · Received November 7, 2008

    Report

    Report Number
    1218950-2008-00617
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Report Date
    October 8, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE PADDLE SET FAILED. THE CUSTOMER'S BIOMEDICAL ENGINEER PERFORMED THE EVALUATION AND ISOLATED THE FAILURE TO THIS ONE PADDLE SET. HE DISCARDED THE PADDLE SET, AND HE HAS RECEIVED THE PADDLE SET REPLACEMENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PADDLE SET FAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTREAM XL DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1