BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CESAR-OMCP-VISUB (HM3000)

    MDR report key: 2013415 · Received February 2, 2011

    Report

    Report Number
    3003768277-2011-00090
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Report Date
    January 5, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZF
    PMA / PMN Number
    K925302
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION SHOWED THAT THE FIELD SERVICE ENGINEER (FSE) FOUND THE GEO CEASER EXTENSION BOARD WAS BURNT. THE BOARD WAS REPLACED AND OPERATION VERIFIED. THE SYSTEM'S END OF SERVICE WAS 2010. THE REPLACEMENT BOARD WAS FROM THE HOSPITAL STOCK.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SCREEN WILL NOT BOOT NO FLUORO AND THERE IS A BURNING SMELL IN THE EQUIPMENT ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CESAR-OMCP-VISUB (HM3000) IZF PHILIPS HEALTHCARE 72239

    Patients

    Seq Age Sex Outcome Treatment
    1