BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART XL

    MDR report key: 1622606 · Received March 2, 2010

    Report

    Report Number
    1218950-2010-00243
    Event Type
    Malfunction
    Date Received
    March 2, 2010
    Report Date
    February 1, 2010
    Manufacturer
    AGILENT TECHNOLOGIES, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THE UNIT DISPLAYED, "ATTACHED CABLE ERROR MESSAGE", WHEN PERFORMING THE SELF TEST. THE FACTORY HAS NOT YET RECEIVED THE DEVICE FOR EVAL, AND 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 THE UNIT DISPLAYED, "ATTACHED CABLE ERROR MESSAGE", WHEN PERFORMING THE SELF TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART XL MKJ AGILENT TECHNOLOGIES, INC. M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1