BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 1873450 · Received October 14, 2010

    Report

    Report Number
    1218950-2010-01955
    Event Type
    Malfunction
    Date Received
    October 14, 2010
    Report Date
    September 16, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED A "CYCLE POWER" SCREEN MESSAGE. THE UNIT WAS EVALUATED AT PHILIPS AND THE FAILURE WAS VERIFIED. THE POWER PCA WAS REPLACED TO RESOLVE THIS FAILURE. THE UNIT PASSED ALL POST SERVICING TESTING AND WAS RETURNED TO THE CUSTOMER SITE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A "CYCLE POWER" SCREEN MESSAGE.

    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