BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERADIUS

    MDR report key: 2033674 · Received February 11, 2011

    Report

    Report Number
    3003768277-2011-00142
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Report Date
    January 14, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZL
    PMA / PMN Number
    K090590
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT IS STILL UNDER INVESTIGATION. THE FOLLOW-UP REPORT WILL BE SENT BY 04/12/2011.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM STOPPED WORKING DURING AN IMPORTANT PROCEDURE; AFTER THEY REBOOTED THE SYSTEM, HE SAW AN ERROR "M053."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERADIUS IZL, MQB IZL PHILIPS HEALTHCARE 718130

    Patients

    Seq Age Sex Outcome Treatment
    1