BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2200890 · Received June 30, 2011

    Report

    Report Number
    1218950-2011-01872
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Report Date
    June 10, 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 BATTERY GOES OUT OF PLACE WHEN THE DEVICE IS MOVED. THE DEVICE WAS EVALUATED BY A PHILIPS FIELD SERVICE ENGINEER. THE SYMPTOM WAS VERIFIED. THE BATTERY EJECT ASSEMBLY WAS REPLACED TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE BATTERY GOES OUT OF PLACE WHEN THE DEVICE IS MOVED.

    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