BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIDERIA NEC MONITOR

    MDR report key: 405997 · Received July 18, 2002

    Report

    Report Number
    MW1025618
    Event Type
    Injury
    Date Received
    July 18, 2002
    Date of Event
    July 13, 2002
    Report Date
    July 18, 2002
    Manufacturer
    NEC
    Product Code
    DRT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    VIDERIA NURSES STATION WENT DOWN DUE TO DEFECTIVE MONITOR IN INTENSIVE CARE UNIT. MONITOR GOES BLANK DUE TO A DEFECTIVE BOARD PREVENTING MONITORING OF PTS. THIS WAS THE SECOND OCCURRENCE FOR THE FACILITY IN TWO DAYS THE FIRST WAS YESTERDAY IN STEPDOWN UNIT TELEMETRY.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 11/21/02: THE CUSTOMER REPORTED THE NEC DISPLAY MONITOR WENT BLANK DUE TO A DEFECTIVE BOARD, PREVENTING THE MONITORING OF PTS. THE NURSE OBSERVED THE BLANK SCREEN AND ATTEMPTED TO REBOOT THE M3150A, BUT THE SYSTEM WOULD NOT REBOOT BECAUSE OF THE NON-FUNCTIONAL DISPLAY MONITOR. THE CUSTOMER REPLACED THE DISPLAY WITH A BACK UP; THE SYSTEM WAS THEN REBOOTED BRINGING THE CENTRAL STATION TO FULL FUNCTIONALITY. THE HOSPITAL BIOMEDICAL ENGINEER INVESTIGATED THE INCIDENT AND DETERMINED THAT THE MONITOR DISPLAY WAS NOT OPERATING. THEY SENT THE MONITOR TO A THIRD PARTY FOR ANALYSIS AND DETEMRINED THAT THE MONITOR'S DRIVER BOARD NEEDED TO BE REPLACED. AFTER THE MONITOR WAS REPAIRED, THE THIRD-PARTY SERVICER RETURNED IT TO THE CUSTOMER FOR FURTHER USE. PHILIPS WAS NOT INVOLVED IN THIS ANALYSIS. DATE MFR MADE AWARE: AUGUST 29, 2002. THERE WERE NO DEATH OR INJURY INVOLVED IN THIS EVENT. THE DISPLAY MONITOR WAS SERVICED BY A THIRD-PARTY SERVICER AND RETURNED TO USE. THERE ARE NO DESIGN CHANGES OR MODIFICATIONS NEEDED FOR THIS MONITOR DISPLAY. MONITORS USED WITH THE M3150A GENERALLY OPERATE 24 HOURS A DAY, 7 DAYS A WEEK. MFR'S REVIEW OF ITS RELIABILITY LIMITS FOR THIS BOARD FAILURE HAS NOT INDICATED THAT ADD'L ACTION IS WARRANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIDERIA NEC MONITOR NEC MODEL LA-1831JMW DRT NEC M3150A *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening