BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCKESSON, NON-REBREATHER OXYGEN MASK

    MDR report key: 3987001 · Received August 4, 2014

    Report

    Report Number
    MW5037648
    Event Type
    Injury
    Date Received
    August 4, 2014
    Date of Event
    July 31, 2014
    Report Date
    August 1, 2014
    Manufacturer
    MCKESSON
    Product Code
    KGB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    OXYGEN TUBING SELF-DISCONNECTS AT NRB MASK CONNECTION. DATES OF USE: (B)(6) 2014 - (B)(6) 2014. DIAGNOSIS FOR USE: SUPPLEMENTAL OXYGENATION TO SEDATED PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455078 MCKESSON, NON-REBREATHER OXYGEN MASK MASK OXYGEN KGB MCKESSON 86-106E 104634

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PATIENT SEDATED WITH PROPROFOL