BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPERATURE ADAPTER CABLE ASSEMBLY

    MDR report key: 1073711 · Received July 1, 2008

    Report

    Report Number
    3023361-2008-00016
    Event Type
    Malfunction
    Date Received
    July 1, 2008
    Date of Event
    July 26, 2007
    Report Date
    July 1, 2008
    Manufacturer
    SPACELABS HEALTHCARE
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    SPACELABS PERFORMED A HEALTH HAZARD EVALUATION IN 2007 WHICH IDENTIFIED THAT MITIGATION IS REQUIRED TO PREVENT POSSIBLE DELAY IN PATIENT CARE. REVIEW OF OUR POST MARKET SURVEILLANCE HAS REVEALED THAT SPACELABS HAD NOT PREVIOUSLY SUBMITTED A REPORT OF THIS ISSUE TO THE FDA.

    Description of Event or Problem · 1

    SPACELABS SERVICE REPRESENTATIVE REPORTED THAT A TOTAL OF 24 TEMPERATURE ADAPTER CABLES PART NUMBER 700-0031-00 WERE RECEIVED AS OUT OF BOX FAILURES. IT WAS REPORTED THAT IN THIS FAILURE MODE, THE CABLES HAVE INTERMITTENT CONTACT PROBLEMS CAUSING ALL VALUES ON THE MONITOR TO BE FLASHING. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEMPERATURE ADAPTER CABLE ASSEMBLY NONE MHX SPACELABS HEALTHCARE OSC 03/07

    Patients

    Seq Age Sex Outcome Treatment
    1 Other