BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPACELABS ULTRAVIEW SL PATIENT MONITOR

    MDR report key: 1902708 · Received November 11, 2010

    Report

    Report Number
    3023361-2010-00074
    Event Type
    Other
    Date Received
    November 11, 2010
    Date of Event
    October 9, 2010
    Report Date
    November 11, 2010
    Manufacturer
    SPACELABS HEALTHCARE
    Product Code
    DSI
    PMA / PMN Number
    K972282
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DATA RETRIEVED FROM THE MONITORING SYSTEM CLEARLY DOCUMENTED THAT A LOW HEART RATE LIMIT ALARM VIOLATION WAS RECOGNIZED BY THE SYSTEM AND AN ALARM ACTIVATED ON (B)(6) 2010 AT 12:40:46 AM. THE INCIDENT REPORT STATED THAT THE STAFF WAS EXPECTING A HIGH PRIORITY ALARM BUT THE MONITOR WAS SET TO PROVIDE A MEDIUM PRIORITY ALARM. THE ALARM TONES WERE SET TO A VERY LOW VOLUME AND ALARM RECORDINGS WAS TURNED OFF. THE HOSPITAL DID CONTINUE TO USE THE MONITOR AND DOCUMENTED THAT THE MONITOR PERFORMED WITHOUT INCIDENT. THE MONITOR WAS TESTED AT THE HOSPITAL BY SPACELABS AND THE HOSPITAL BIOMED AND PERFORMED TO SPECIFICATION. NO ONE HAS BEEN INJURED AS A RESULT OF THIS ISSUE. THE HOSPITAL IS CONTINUING TO USE THE EQUIPMENT. FOLLOW-UP TRAINING OF THE HOSPITAL'S CLINICAL EDUCATION STAFF WAS CONDUCTED ON (B)(6). WE HAVE CONCLUDED THAT NO FURTHER ACTION IS REQUIRED AND CONSIDER THIS ISSUE CLOSED.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT AN ALARM ON A BEDSIDE MONITOR DID NOT SOUND DURING A PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1