BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUKUDA DENSHI MODEL DS-5700 CENTRAL STATION

    MDR report key: 846636 · Received December 15, 2004

    Report

    Report Number
    9611031-2004-00001
    Event Type
    Malfunction
    Date Received
    December 15, 2004
    Manufacturer
    FUKUDA DENSHI CO., LTD.
    Product Code
    DSI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FUKUDA DENSHI USA SERVICE WAS NOTIFIED ON 11/22/04 BY SERVICE GROUP THAT PERFORMED SYSTEM INSTALLATION THAT DS-5700 CENTRAL MONITOR WAS EXHIBITING INCORRECT PT WAVE FORM AND NUMERIC DATA OUTPUT TO SLAVE MONITOR, CONNECTED BY MEANS OF SLAVE OUTPUT CONNECTOR. STATED PROBLEM WAS THAT FOLLOWING PERFORMING BED TRANSFER FUNCTION PT INFO (AT SLAVE MONITOR ONLY) COULD BE REARRANGE TO SHOW INCORRECT PT DATA FOR GIVEN BED SECTOR. HOSPITAL WAS CONTACTED UPON NOTIFICATION. BIOMEDICAL ENGINEERING MGR CONFIRMED ABOVE NOTED SYMPTOMS AND STATED THAT SLAVE MONITORS HAD BEEN REMOVED FROM THE DS-5700 SYSTEM CONFIGURATION UPON BECOMING AWARE OF ISSUE. OUTPUT TO DS-5700 MAIN DISPLAY WAS OPERATING AS SPECIFIED WITH NO RISK TO MONITORED PTS. FUKUDA DENSHI CO. LTD ENGINEERING WAS NOTIFIED OF PROBLEM AND REPORTED ON 11/24/04 THAT NOTED ISSUE WAS DUPLICATED WHEN THE DISPLAY CONFIGURATION KEY WAS NOT CLICKED, FOLLOWING A BED TRANSFER OPERATION. THE ISSUE WAS ALSO VERIFIED TO BE SPECIFIC TO REV. 04 . 02 DS-5700 S/W AND EFFECTS ONLY DATA FROM SLAVE OUT CONNECTOR. FUKUDA DENSHI CO. LTD ENGINEERING ELMINATED NECESSITY TO MANUALLY CLICK SCREEN CONFIGURATION ENTER KEY FOLLOWING BED TRANSFER FUNCTION, AS AN ADDITION TO A SCHEDULED SOFTWARE UPDATE RELEASE. VERSION .04 . 04 WAS FULLY VALIDATED AND RELEASED ON 12/02/04. USER SITE NOTED ABOVE, WAS UPDATED TO VERSION 04 . 04 ON 12/09/04 BY FUKUDA DENSHI REPS. UPON SOFTWARE UPDATE, SLAVE DISPLAYS WERE RE-CONNECTED AND VERIFIED BY FUKUDA DENSHI REP TO OPERATE AS SPECIFIED. HOSPITAL BIO-MEDICAL MANAGER WAS CONTACTED BY FUKUDA DENSHI REGULATORY AFFAIRS ON 12/10/04 AND AGAIN ON 12/13/04 TO VERIFY THAT SYSTEM CONTINUED TO OPERATE AS SPECIFIED WITH NO NOTED CONDITION THAT LEADS TO FILING OF COMPLAINT. NO ISSUES WERE REPORTED. A REVIEW OF INSTALLATION RECORDS EXHIBITED THAT REPORTING HOSPITAL IS ONLY SITE THAT UTILIZES OPTIONAL BED TRANSFER WITH SLAVE OUTPUT AND S/W VERSION 04.02. A PRECAUTIONARY SERVICE BULLETIN (#2004-002) WAS DISTURBED TO ALL DISTRIBUTORS AND SERVICE PERSONNEL SPECIFYING ISSUE AND STATING THAT SLAVE OUTPUT CONECTORS SHOULD NOT BE USED ON DS-5700'S WITH S/W. VERSION 04.02. ALL SYSTEMS WILL BE UPDATED AT NEXT SCHEDULED SERVICE. FUKUDA DENSHI SERVICE WILL CONTINUE TO MONITOR ISSUE, HOWEVER, NO FURTHER ACTION IS ANTICIPATED.

    Description of Event or Problem · 1

    ON NOVEMBER 24TH, THE HOSPS MEDWATCH REPORT WAS RECEIVED FROM THE FDA. THE DESCRIPTION ON THE FORM WAS AS FOLLOWS: FUKUDA DENSHI TELEMETRY SYSTEM. INFO THAT IS DISPLAYED AT THE SLAVE MONITOR IS NOT THE SAME AS DISPLAYED AT THE CENTRAL MONITOR. FOR EXAMPLE, BED 2'S WAVEFORM AND NUMERICS ARE DISPLAYED IN BED 4'S SECTOR. THE PTS NAME IS DISPLAYED IN ITS PROPER SECTOR AND BED 4'S WAVEFORM AND NUMERICS ARE DISPLAYED IN BED 2'S SECTORS. SO THE WAVEFORM AND NUMERICS ARE NOT FOR THE RIGHT PT, SO THE NURSE MAY CHART THE WRONG INFO FOR THAT PT. DEVICE USAGE PROBLEM: OTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUKUDA DENSHI MODEL DS-5700 CENTRAL STATION CENTRAL STATION MONITOR/TELEMETRY SYSTEM DSI FUKUDA DENSHI CO., LTD. DS-5700 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other