BEUDAMED
    FDA Adverse Event Death Summary report: N

    CIRCUIT ADT SINGLE LIMB X AIROX II

    MDR report key: 1753472 · Received July 9, 2010

    Report

    Report Number
    2936999-2010-00948
    Event Type
    Death
    Date Received
    July 9, 2010
    Date of Event
    June 8, 2010
    Report Date
    June 9, 2010
    Manufacturer
    COVIDIEN - FORMERLY TYCO HEALTHCARE
    Product Code
    CAI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS EVALUATED AND THE FAILURE COULD NOT BE DUPLICATED. THE DEVICE PASSED ALL CONFORMITY TESTS AND IS COMPLIANT WITH INTERNATIONAL STANDARDS. THIS DEVICE IS SUBJECTED TO SEC, 868.5240 FOR EXEMPTION FROM THE PREMARKET APPLICATION (510K).

    Description of Event or Problem · 1

    COVIDIEN (B)(4) RECEIVED A REPORT IN REGARD TO AN INCIDENT RESULTING IN A PT DEATH. THE CUSTOMER STATED THE PT WAS LEFT ALONE AT HOME FOR ONE AND A HALF HOURS WHILE FAMILY WENT OUT. THE UNIT'S ALARM SOUNDED AND THE PT'S FAMILY DISCOVERED THAT THE HYGROBAC DISENGAGED FROM PT'S CIRCUIT. THE PT WAS IN CARDIO-RESPIRATORY ASSET WHEN DISCOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIRCUIT ADT SINGLE LIMB X AIROX II ANESTHESIA BREATHING CIRCUIT CAI COVIDIEN - FORMERLY TYCO HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death HYGROBAC