BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS ULTRAVIEW SL COMMAND MODULE

    MDR report key: 1931758 · Received December 8, 2010

    Report

    Report Number
    3023361-2010-00079
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    November 6, 2010
    Report Date
    December 8, 2010
    Manufacturer
    SPACELABS HEALTHCARE
    Product Code
    DSI
    PMA / PMN Number
    K050605
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SPACELABS WAS NOT ALLOWED ACCESS TO THE EQUIPMENT. FULL DISCLOSURE PRINTOUTS PROVIDED BY THE HOSPITAL REGARDING THE INCIDENT CLEARLY INDICATES THAT THE BEDSIDE MONITOR DID RECOGNIZE AND ALARM ON A RUN CONDITION. SPACELABS MONITORS DO NOT ALARM ON ATRIAL FIBRILLATION AND THIS WAS EXPLAINED TO THE CUSTOMER. ALL ALARMING CONDITIONS ARE IDENTIFIED IN THE SPACELABS OPERATOR'S MANUAL. THE HOSPITAL IS CONTINUING TO USE THE EQUIPMENT TO MONITOR PATIENTS. WE CONSIDER THIS ISSUE CLOSED.

    Description of Event or Problem · 1

    THE STAFF AT (B)(6) MEDICAL CENTER REPORTED THAT A MONITOR FAILED TO ALARM ON ATRIAL FIBRILLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACELABS ULTRAVIEW SL COMMAND MODULE MULTIPARAMETER MODULE DSI SPACELABS HEALTHCARE 91496

    Patients

    Seq Age Sex Outcome Treatment
    1