BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART XL

    MDR report key: 1672175 · Received April 29, 2010

    Report

    Report Number
    1218950-2010-00605
    Event Type
    Malfunction
    Date Received
    April 29, 2010
    Report Date
    March 31, 2010
    Manufacturer
    AGILENT TECHNOLOGIES, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE BATTERY FAILED TO STAY INSERTED. THE UNIT WAS EVALUATED AT PHILIPS AND THE FAILURE WAS VERIFIED. REPLACEMENT OF THE BATTERY LATCH RESOLVED THE FAILURE. THE UNIT PASSED ALL POST SERVICING TESTING AND WAS RETURNED TO THE CUSTOMER SITE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE BATTERY FAILED TO STAY INSERTED.

    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