BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 1740906 · Received June 25, 2010

    Report

    Report Number
    1218950-2010-01013
    Event Type
    Malfunction
    Date Received
    June 25, 2010
    Report Date
    February 10, 2010
    Manufacturer
    AGILENT TECHNOLOGIES, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED BEING UNABLE TO CHARGE TO MORE THAN 20 JOULES. THE DEVICE WAS EVALUATED LOCALLY. THE SYMPTOM COULD NOT BE DUPLICATED. THE DEVICE WAS RETURNED TO SERVICE AFTER PASSING ALL TESTING. AS OF 6/18/10, THE CUSTOMER HAS NOT CALLED BACK REGARDING THIS ISSUE WITH THIS DEVICE. WE CANNOT DETERMINE THE CAUSE SINCE THE SYMPTOM COULD NOT BE DUPLICATED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING UNABLE TO CHARGE TO MORE THAN 20 JOULES.

    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