BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPERATURE ADAPTER CABLE ASSEMBLY

    MDR report key: 1073706 · Received July 1, 2008

    Report

    Report Number
    3023361-2008-00019
    Event Type
    Malfunction
    Date Received
    July 1, 2008
    Date of Event
    October 11, 2007
    Report Date
    July 1, 2008
    Manufacturer
    SPACELABS HEALTHCARE
    Product Code
    FLL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    SPACELABS PERFORMED A HEALTH HAZARD EVALUATION ON SEPTEMBER 5, 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. WE ARE NOW REPORTING THIS ISSUE AS REQUIRED BY 21 CFR 803.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A TEMPERATURE ADAPTER CABLE PART NUMBER 700-0031-00 WAS CAUSING AN INTERMITTENT CONNECTION. IT WAS REPORTED THAT IN THIS FAILURE MODE, THE TEMPERATURE READING COULD NOT BE VIEWED ON THE MONITOR. NO INJURIES WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other