BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUCARE

    MDR report key: 5454995 · Received February 18, 2016

    Report

    Report Number
    MW5060417
    Event Type
    Injury
    Date Received
    February 18, 2016
    Date of Event
    February 16, 2016
    Report Date
    February 18, 2016
    Manufacturer
    RESMED GERMANY INC.
    Product Code
    CAT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    TUBING HAD A TEAR AND OXYGEN WAS NOT GETTING TO THE PATIENT. DIAGNOSIS OR REASON FOR USE: OXYGEN DELIVERY. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101559 ACUCARE HIGH FLOW NASAL CANNULA CAT RESMED GERMANY INC. HFNC 1127973

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention