BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 1982196 · Received January 18, 2011

    Report

    Report Number
    1218950-2011-00175
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Report Date
    December 24, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE AC POWER LED WAS NOT LIT. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. THE UNIT WAS EVALUATED LOCALLY BY A PHILIPS FIELD SERVICE ENGINEER AND THE FAILURE WAS VERIFIED. THE POWER SUPPLY WAS REPLACED TO RESOLVE THIS FAILURE. THE UNIT PASSED ALL POST-SERVICING TESTING AND REMAINS AT THE CUSTOMER SITE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE AC POWER LED WAS NOT LIT. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    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