BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART XL

    MDR report key: 634833 · Received June 9, 2005

    Report

    Report Number
    1218950-2005-00171
    Event Type
    Malfunction
    Date Received
    June 9, 2005
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THIS UNIT SHOWED A DEFIB FAILURE CYCLE POWER SCREEN MESSAGE AS WELL AS ERROR CODES 20, 02000, 90008 IN THE SYSTEM LOG. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA