BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACE LABS MEDICAL INC.

    MDR report key: 558869 · Received November 15, 2004

    Report

    Report Number
    MW1033771
    Event Type
    Malfunction
    Date Received
    November 15, 2004
    Date of Event
    September 15, 2004
    Report Date
    November 11, 2004
    Manufacturer
    SPACE LABS MEDICAL, INC.
    Product Code
    DRT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MONITOR HAD A HOLE BURNED IN THE CASE. BURN UNIT- NO PT IN ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACE LABS MEDICAL INC. UCW MONITOR DRT SPACE LABS MEDICAL, INC. 903851 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *