BEUDAMED
    FDA Adverse Event Other Summary report: N

    DISPLAY FOR SPACELABS PATIENT MONITOR

    MDR report key: 1644573 · Received March 25, 2010

    Report

    Report Number
    3023361-2010-00005
    Event Type
    Other
    Date Received
    March 25, 2010
    Date of Event
    February 23, 2010
    Report Date
    March 24, 2010
    Manufacturer
    SPACELABS HEALTHCARE
    Product Code
    DXJ
    PMA / PMN Number
    K932724
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SPACELABS CONTACTED THE CUSTOMER AND LEARNED FROM THE HOSPITAL'S VP OF QUALITY AND REGULATORY COMPLIANCE THAT THE DISPLAY HAD COME UNPLUGGED FROM THE PT MONITOR. THE STAFF WAS UNABLE TO CORRECT THE PROBLEM AND BIO-MED WAS NOTIFIED. THE CABLE BETWEEN THE MONITOR AND THE DISPLAY WAS RECONNECTED TO THE DISPLAY AND THE DISPLAY THEN FUNCTIONED TO SPECIFICATION. NO SPECIFIC MODEL NUMBER OR SERIAL NUMBER INFO IS AVAILABLE FROM THE SITE. NO FURTHER SERVICE WAS REQUIRED. ALL EQUIPMENT IS CURRENTLY IN USE MONITORING PATIENTS. THERE IS NO KNOWN ADVERSE EVENT TO THE PT WHO THE HOSPITAL REPORTED AS STABLE AT TIME OF DISCHARGE. THIS REPORT IS CONSIDERED FINAL AND THE ISSUE CLOSED.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT A PT MONITOR DISPLAYING ALL OF THE PATIENTS VITAL INFO WENT BLANK AND THAT NO PHYSICIAN INTERACTION WITH THE MONITOR (TURNING IT OFF AND ON, CHANGING POWER SOURCES, HITTING EVERY BUTTON, ETC) COULD REVIVE IT. THE MONITOR HAD TO BE EMERGENCY SWITCHED OUT WITH ONE IN ANOTHER ROOM. THE PT WENT COMPLETELY UNMONITORED FOR SEVERAL MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPLAY FOR SPACELABS PATIENT MONITOR 19" DISPLAY W/ TOUCH SCREEN DXJ SPACELABS HEALTHCARE 94260-19

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Life Threatening SPACELABS: MODEL 91387 PT MONITOR