BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CESAR-OMCP-VISUB (HM3000)

    MDR report key: 2239208 · Received August 16, 2011

    Report

    Report Number
    3003768277-2011-00503
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Report Date
    July 21, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZF
    PMA / PMN Number
    K925302
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION SHOWED THAT THE FIELD SERVICE ENGINEER (FSE) TROUBLESHOT THE SYSTEM AND FOUND A BAD FOOT PEDAL. AFTER REPLACEMENT OF THE FOOT PEDAL THE PROBLEM DID NOT RECUR. THE PATIENT ON THE TABLE WAS BROUGHT TO ANOTHER ROOM WHERE THE CASE WAS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT X-RAY IS NOT WORKING WHILE PATIENT IS ON THE TABLE. NO ERROR MESSAGES WERE SHOWN ON THE MONITOR.

    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