BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CESAR-OMCP-VISUB (HM3000)

    MDR report key: 2180727 · Received May 5, 2011

    Report

    Report Number
    3003768277-2011-00363
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Report Date
    April 14, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZF
    PMA / PMN Number
    K925302
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FIELD SVC ENGINEER (FSE) WAS DISPATCHED TO THE SITE AND FOUND A PROBLEM IN THE VIEWING SUBSYSTEM CAUSED BY THE TEMPORAL PROCESSING BOARD (TPB) BOARD. THE FSE RECOMMENDED REPLACING THIS TPB BOARD, THE CUSTOMER HAD BROUGHT THE BOARD AND HAD THE FSE REPLACE IT. THE SYSTEM WORKS CORRECTLY AND IS BACK IN OPERATIONS. NO FURTHER ACTIONS REQUIRED. NO RISK FOR THE PT, USER OR BYSTANDERS.

    Description of Event or Problem · 1

    THE EQUIPMENT FAILS INTERMITTENTLY.

    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