BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACE LABS ULTRAVIEW SL PATIENT MONITOR

    MDR report key: 1933200 · Received December 15, 2010

    Report

    Report Number
    3023361-2010-00080
    Event Type
    Malfunction
    Date Received
    December 15, 2010
    Date of Event
    October 6, 2010
    Report Date
    December 14, 2010
    Manufacturer
    SPACELABS HEALTHCARE
    Product Code
    DSI
    PMA / PMN Number
    K972282
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF OUR MEDICAL DEVICE REPORTING HAS REVEALED THAT SPACELABS HAD NO PREVIOUSLY SUBMITTED A REPORT OF THIS INCIDENT TO THE FDA. WE ARE NOW REPORTING THIS ISSUE AS REQUIRED BY 21 CFR 803. THE MONITOR WAS TESTED BY SPACELABS BOTH AT THE HOSPITAL AND AT THE SPACELABS FACILITY IN (B)(4). TESTING AT BOTH SITES CONFIRMED THAT THE DEVICE WAS WORKING TO SPECIFICATION. THE INVESTIGATION MADE NOTE OF A NORMAL OPERATING CONDITION WHERE THE MESSAGE AREA WOULD ALTERNATELY DISPLAY THE "ALARM SUSPEND" MESSAGE AND ONE OF TWO OTHER MESSAGES; "NOISY SIGNAL" OR "LEADS OFF". THIS COULD BE INTERPRETED AS THE "ALARM SUSPEND" TURNING ON AND OFF. WE ALSO NOTED SOME CONFUSION AS WHETHER THE MESSAGE OBSERVED BY THE USER WAS "ALARM SUSPENDED" OR "ECG PROCESSING SUSPENDED". SPACELABS HAS CONDUCTED ADDITIONAL TRAINING IN ALL DEPARTMENTS AT (B)(4) SPECIFICALLY COVERING THE DISPLAYED MESSAGES. AT THE HOSPITAL'S DIRECTION THE DEFAULT SETTINGS WERE CHANGED TO TURN OFF THE "ECG SUSPEND" FUNCTION. SPACELABS HAS NOT RECEIVED ANY SIMILAR REPORTS SINCE THIS PRODUCT'S INTRODUCTION IN 1997. WE HAVE CONCLUDED THAT NO FURTHER ACTION IS REQUIRED AND CONSIDER THIS ISSUE CLOSED.

    Description of Event or Problem · 1

    THE STAFF AT BAY MEDICAL CENTER REPORTED THAT A BEDSIDE MONITOR APPEARED TO ACTIVATE THE ALARM TONE SUSPEND FUNCTION BY ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACE LABS ULTRAVIEW SL PATIENT MONITOR MULTIPARAMETER PATIENT MONITOR DSI SPACELABS HEALTHCARE 91387

    Patients

    Seq Age Sex Outcome Treatment
    1