BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDITH1000

    MDR report key: 4379902 · Received December 29, 2014

    Report

    Report Number
    MW5039890
    Event Type
    Injury
    Date Received
    December 29, 2014
    Date of Event
    December 29, 2014
    Report Date
    December 29, 2014
    Manufacturer
    VITAL SIGNS
    Product Code
    BYD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    GE VITAL SIGNS EDITH1000 HEAT/MOISTURE FILTER (A COMPONENT OF VITALSIGNS ADULT CIRCLE BREATHING CIRCUIT LOT 10293827 - GE MEDICAL SYSTEMS (B)(6)) DEVICE FAILED DURING USE, RESULTING IN FAILURE TO VENTILATE PATIENT. THIS IS ONE OF NUMEROUS FAILURES OF THE SAME PRODUCT IN PAST 3 WEEKS OTHER EXAMPLES OF THE SAME LOT IDENTIFIED AS FAULTY VISUAL INSPECTION REVEALS IMPERFECTIONS IN INJECTION-MOULDED HOUSING - IT IS SUSPECTED THAT REPROCESSED/RECYCLED PLASTIC WAS USED IN MANUFACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854704 EDITH1000 EDITH1000 BYD VITAL SIGNS A8E520AX 10293827

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention