BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXBLEND OXYGEN AIR PROPORTIONERS

    MDR report key: 4877627 · Received June 24, 2015

    Report

    Report Number
    4877627
    Event Type
    Malfunction
    Date Received
    June 24, 2015
    Date of Event
    January 5, 2015
    Report Date
    June 24, 2015
    Manufacturer
    MAXTEC, INC
    Product Code
    BZR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    OXYGEN LEAK IN THE BABY WARMER. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407967 MAXBLEND OXYGEN AIR PROPORTIONERS BLENDER, OXYGEN BZR MAXTEC, INC R204P05 *

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY NO OTHER THERAPIES