BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2200925 · Received June 30, 2011

    Report

    Report Number
    1218950-2011-01867
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Report Date
    June 7, 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 DEVICE WAS NOT CHARGING THE BATTERY. THERE WAS NO REPORT OF PT INVOLVEMENT. A PHILIPS FIELD SERVICE ENGINEER WENT TO THE CUSTOMER SITE TO EVALUATE THE DEVICE. REPLACING THE POWER SUPPLY RESOLVED THIS FAILURE. THE DEVICE PASSED ALL TESTING AND REMAINS AT THE CUSTOMER SITE. WE CONSIDER THIS TO HAVE BEEN A POWER SUPPLY MALFUNCTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE WAS NOT CHARGING THE BATTERY. THERE WAS NO REPORT OF PT INVOLVEMENT.

    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