BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UVSL COMMAND MODULE

    MDR report key: 1172737 · Received September 22, 2008

    Report

    Report Number
    3023361-2008-00063
    Event Type
    Malfunction
    Date Received
    September 22, 2008
    Date of Event
    August 15, 2008
    Report Date
    September 22, 2008
    Manufacturer
    SPACELABS MEDICAL
    Product Code
    MHX
    PMA / PMN Number
    K972502
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    SPACELABS TESTED THE UNIT AND DETERMINED AN INTEGRATED CIRCUIT HAD FAILED. THE SYSTEM PERFORMED TO SPECIFICATION AFTER THE INTEGRATED CIRCUIT WAS REPLACED. THE INTEGRATED CIRCUIT HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS. SPACELABS IS CONTINUING ITS INVESTIGATION INTO THIS ISSUE AND WILL SUPPLEMENT THIS MDR AS APPROPRIATE.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT, DURING TESTING, THE COMMAND MODULE DID NOT PROVIDE AN APPROPRIATE ECG OUTPUT SIGNAL TO AN EXTERNAL DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UVSL COMMAND MODULE NONE MHX SPACELABS MEDICAL 91496-1BGMR

    Patients

    Seq Age Sex Outcome Treatment
    1