BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER SUPPLY FOR MODEL 94266 DISPLAY

    MDR report key: 1623186 · Received February 23, 2010

    Report

    Report Number
    3023361-2010-00003
    Event Type
    Malfunction
    Date Received
    February 23, 2010
    Date of Event
    January 31, 2010
    Report Date
    February 22, 2010
    Manufacturer
    SPACELABS HEALTHCARE
    Product Code
    DXJ
    PMA / PMN Number
    K932724
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION IS ANTICIPATED BUT NOT YET BEGUN. SPACELABS HAS PROVIDED THE CUSTOMER A REPLACEMENT. SPACELABS IS WORKING WITH OUR SUPPLIER TO INVESTIGATE THE REPORT. ADDITIONAL INFORMATION WILL BE PROVIDED AS SOON AS IT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED SMOKE AND SPARKS FROM POWER SUPPLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWER SUPPLY FOR MODEL 94266 DISPLAY POWER SUPPLY DXJ SPACELABS HEALTHCARE 010-1840-00

    Patients

    Seq Age Sex Outcome Treatment
    1 SPACELABS MODEL 94266 DISPLAY