BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CESAR-OMCP-VISUB (HM3000)

    MDR report key: 2002537 · Received January 28, 2011

    Report

    Report Number
    3003768277-2011-00084
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Report Date
    January 3, 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 INVESTIGATION FOUND THAT THE CUSTOMER INFORMED US OF A POWER OUTAGE. THE FIELD SERVICE ENGINEER (FSE) REPORTED THAT THE UNIT HAS A PROBLEM WITH THE DIGITAL WHICH RESTARTS SPONTANEOUSLY AS A RESULT THE DISC IMAGE WAS REFORMATTED. IN ADDITION, ONE OF THE PANELS IN THE CAMERA CONTROL CABINET FAILS INTERMITTENTLY, WHICH REQUIRED REPLACEMENT OF THE IDM BOARD.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT HAS A PROBLEM WITH THE IMAGE PROCESSING WHICH RESTARTS SPONTANEOUSLY.

    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