BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART XL

    MDR report key: 2213868 · Received August 5, 2011

    Report

    Report Number
    1218950-2011-02277
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Report Date
    July 11, 2011
    Manufacturer
    AGILENT TECHNOLOGIES, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE UNIT DOES NOT STAY POWERED ON WHEN REMOVED FROM AC POWER. THERE WAS NO REPORT OF PT INVOLVEMENT. THE CUSTOMER WAS SENT A NEW BATTERY. AS OF (B)(6) 2011 THERE HAVE BEEN NO FURTHER CALLS FROM THIS CUSTOMER REGARDING THIS ISSUE. WE CONSIDER THAT REPLACING THE BATTERY RESOLVED THE FAILURE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT DOES NOT STAY POWERED ON WHEN REMOVED FROM AC POWER. THERE WAS NO REPORT OF PT INVOLVEMENT.

    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