BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTREAM XLT

    MDR report key: 1729606 · Received June 16, 2010

    Report

    Report Number
    1218950-2010-00913
    Event Type
    Malfunction
    Date Received
    June 16, 2010
    Report Date
    May 17, 2010
    Manufacturer
    AGILENT TECHNOLOGIES, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K992543
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THE UNIT WOULD NOT POWER UP. THIS COMPLAINT IS STILL BEING INVESTIGATED. A F/U REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE UNIT WOULD NOT POWER UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTREAM XLT MKJ AGILENT TECHNOLOGIES, INC. M3500B

    Patients

    Seq Age Sex Outcome Treatment
    1