BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2070807 · Received April 15, 2011

    Report

    Report Number
    1218950-2011-01043
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Report Date
    March 21, 2011
    Manufacturer
    AGILENT TECHNOLOGIES, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS CUSTOMER REPORTED AN UNEXPECTED SHUTDOWN DURING USE OF THE DEVICE (CARDIOVERSION). THERE WAS NO NEGATIVE PATIENT IMPACT. THE USERS SWITCHED TO A DIFFERENT DEFIBRILLATOR TO DELIVER THERAPY TO THE PATIENT. THIS COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THIS CUSTOMER REPORTED AN UNEXPECTED SHUTDOWN DURING USE OF THE DEVICE (CARDIOVERSION). THERE WAS NO NEGATIVE PATIENT IMPACT. THE USERS SWITCHED TO A DIFFERENT DEFIBRILLATOR TO DELIVER THERAPY TO THE PATIENT.

    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