BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2945870 · Received January 7, 2013

    Report

    Report Number
    1218950-2013-00051
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Report Date
    December 13, 2012
    Manufacturer
    AGILENT TECHNOLOGIES, INC
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE DEVICE WAS NOT PASSING THE DISCHARGE TESTS. THERE WAS NO REPORTED PATIENT INVOLVEMENT. THE COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE WAS NOT PASSING THE DISCHARGE TESTS. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8653 HEART START XL MKJ AGILENT TECHNOLOGIES, INC M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1