BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONY LMD-1950MD MEDICAL MONITOR

    MDR report key: 1057055 · Received May 28, 2008

    Report

    Report Number
    2246606-2008-00001
    Event Type
    Malfunction
    Date Received
    May 28, 2008
    Date of Event
    March 29, 2008
    Report Date
    May 12, 2008
    Manufacturer
    SONY EMCS CORPORATION
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    SONY ELECTRONICS RECEIVED MEDWATCH UF/IMPORTER REPORT# 5233000000-2008-8004 WHICH WAS FORWARDED TO SONY ELECTRONICS BY FDA. SONY MONITOR WAS MENTIONED IN THE REPORT STATING, "IN ADDITION, THE VIDEO IMAGE ON THE SONY DISPLAY WOULD BECOME DISTORTED THEN BLACKOUT WITH AN ERROR MESSAGE. THE ERROR MESSAGE READS NO RGB CONNECTION. THE VIDEO RETURNS TO NORMAL WHEN THE ABC ENERGY OUTPUT IS TURNED OFF AT THE FOOTSWITCH." UPON INVESTIGATING THE RELEVANT DATA, THERE WAS NO MALFUNCTION OF THE SONY FLAT PANEL MONITOR. THE RGB CABLE CONNECTING THE MONITOR TO THE IMAGING DEVICE EITHER CAME LOOSE OR THE IMAGING DEVICE INTERRUPTED THE SIGNAL TO THE MONITOR. IN EITHER EVENT, THE MONITOR FUNCTIONED PROPERLY BY REPORTING THE ERROR MESSAGE "NO RGB CONNECTION." THIS REPORT IS BEING SUPPLIED TO FOLLOW-UP ON THE MEDWATCH REPORT SENT TO SONY MEDICAL BY THE FDA REGARDING UF/IMPORTER REPORT.EVALUATED BY MFR: NOT RETURNED TO MFR. DEVICE MANUFACTURE DATE: UNK. LABELED FOR SINGLE USE: NO. USAGE OF DEVICE: UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SONY LMD-1950MD MEDICAL MONITOR SYSTEM, IMAGE PROCESSING, RADIOLOGICAL LLZ SONY EMCS CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *