BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT CIRCUIT SINGLE LIMB AIROX GEN II

    MDR report key: 3134302 · Received May 23, 2013

    Report

    Report Number
    2936999-2013-00372
    Event Type
    Malfunction
    Date Received
    May 23, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 23, 2013
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR FAILURE INVESTIGATION. THIS DEVICE IS SUBJECTED TO SEC. 868.5240 FOR EXEMPTION FROM THE PREMARKET APPLICATION (510K). (B)(4).

    Description of Event or Problem · 1

    CUSTOMER STATES: DURING USE AT HOME, A GREAT LEAKAGE OCCURRED AND THE NORMAL VENTILATION FUNCTION WAS NOT AVAILABLE. CONFIRMED A CRACK IN A HOOK OF THE TOP COVER OF EXHALATION VALVE AND IT WAS ALMOST TO BE DETACHED. NO PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230257 ADULT CIRCUIT SINGLE LIMB AIROX GEN II ADULT CIRCUIT SINGLE LIMB JOH COVIDIEN/FORMERLY TYCO HEALTHCARE AIROX GEN II 120200186

    Patients

    Seq Age Sex Outcome Treatment
    1