BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 1874356 · Received October 11, 2010

    Report

    Report Number
    1218950-2010-01901
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Report Date
    September 11, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 LOCALIZED THIS ISSUE TO THE EXTERNAL DATA CARD BEING FULL. THE CUSTOMER RESOLVED THE ISSUE BY REMOVING THE DATA CARD AND CYCLING THE POWER.

    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