BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 1854376 · Received September 29, 2010

    Report

    Report Number
    1218950-2010-01767
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Report Date
    August 30, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE UNIT SHOWED THE ERROR 10003 [SYSTEM FAILURE CYCLE POWER]. THE PHILIPS CUSTOMER SERVICE CENTER ADVISED THE CUSTOMER TO REMOVE THE DATA CARD AND CYCLE THE POWER TO RESOLVE THE ISSUE. NOTE THAT THIS ISSUE IS DUE TO THE EXTERNAL DATA CARD BEING FULL. ANOTHER WAY TO RESOLVE THE ISSUE WOULD BE TO CLEAR ALL THE STORED EVENTS ON THE DATA CARD. WE ARE CONSIDERING THIS A MALFUNCTION WHERE THE EXTERNAL DATA CARD BEING FULL PREVENTED THE DEVICE FROM POWERING UP PROPERLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT SHOWED THE ERROR 10003 [SYSTEM FAILURE CYCLE POWER].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEART START XL MKJ PHILIPS HEALTHCARE M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1