BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2123604 · Received June 10, 2011

    Report

    Report Number
    1218950-2011-01658
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Report Date
    May 16, 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 FAILED TO POWER ON AND FAILED TO CHARGE THE BATTERY. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. THE CUSTOMER WAS SHIPPED BOTH THE AC POWER SUPPLY AND THE BATTERY PCA TO RESOLVE THIS FAILURE. THE CUSTOMER PERFORMED THE REPAIR. SINCE MULTIPLE PARTS WERE REPLACED, AND SINCE PHILIPS DID NOT EVALUATE THE DEVICE, WE ARE UNABLE TO DETERMINE THE CAUSE OF THE CUSTOMER'S REPORTED SYMPTOMS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT FAILED TO POWER ON AND FAILED TO CHARGE THE BATTERY. THERE WAS NO REPORT OF PATIENT 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