BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS MEDICAL, INC.

    MDR report key: 459309 · Received May 9, 2003

    Report

    Report Number
    MW1028353
    Event Type
    Malfunction
    Date Received
    May 9, 2003
    Date of Event
    April 23, 2003
    Report Date
    April 23, 2003
    Manufacturer
    SPACELABS MEDICAL, INC.
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS FACILITY HAS HAD SEVEN SPACELABS MEDICAL MODEL 90385 (UCW) MONITORS BREAK AT THE SWIVEL BASE. THE MONITOR USES A "BALL AND SOCKET" ARRANGEMENT FOR MOVEMENT. THE BREAKS HAVE BEEN OF SEVERAL VARIETIES. EITHER THE "BALL" SECTION HAS BROKEN, THE SLIDE MECHANISM HAS BROKEN, OR THE PLASTIC STUD THAT HOLDS THE "BALL" IN THE "SOCKET" HAS BROKEN OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACELABS MEDICAL, INC. PHYSIOLOGICAL MONITOR MHX SPACELABS MEDICAL, INC. 90385 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *