BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 1882793 · Received October 22, 2010

    Report

    Report Number
    1218950-2010-02012
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Report Date
    September 22, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), THE UNIT WAS EVALUATED AT PHILIPS, AND THE FAILURE WAS VERIFIED. REPLACEMENT OF THE POWER PCA RESOLVED THE FAILURE. THE UNIT PASSED ALL TESTING AND WAS SHIPPED BACK TO THE CUSTOMER SITE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT FAILED TO POWER UP.

    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