BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 1734140 · Received June 21, 2010

    Report

    Report Number
    1218950-2010-00934
    Event Type
    Malfunction
    Date Received
    June 21, 2010
    Report Date
    July 17, 2009
    Manufacturer
    AGILENT TECHNOLOGIES INC
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED GETTING A SYSTEM FAILURE CYCLE POWER, ERROR F0006 MSG. THE DEVICE WAS EVALUATED LOCALLY. THE SYMPTOM WAS VERIFIED. THE DATA CARD WAS REFORMATTED TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED GETTING A SYSTEM FAILURE CYCLE POWER, ERROR F0006 MSG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEART START XL MKJ AGILENT TECHNOLOGIES INC M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1