BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPERATURE ADAPTER CABLE ASSEMBLY

    MDR report key: 1073713 · Received July 1, 2008

    Report

    Report Number
    3023361-2008-00021
    Event Type
    Malfunction
    Date Received
    July 1, 2008
    Date of Event
    October 17, 2007
    Report Date
    July 1, 2008
    Manufacturer
    SPACELABS HEALTHCARE
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 PT CARE. REVIEW OF OUR POST MARKET SURVEILLANCE HAS REVEALED THAT SPACELABS HAD NOT PREVIOUSLY SUBMITTED A REPORT OF THIS ISSUE TO THE FDA. WE ARE NOW REPORTING THIS ISSUE AS REQUIRED BY 21 CFR 803.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT TEMPERATURE ADAPTER CABLE HAS A BAD CONNECTION. IN THIS FAILURE MODE, THE TEMPERATURE PARAMETER APPEARS AND DISAPPEARS FROM THE MONITOR SCREEN. 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