BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATUS 5

    MDR report key: 20953116 · Received December 16, 2024

    Report

    Report Number
    MW5163669
    Event Type
    Malfunction
    Date Received
    December 16, 2024
    Date of Event
    November 27, 2024
    Report Date
    December 11, 2024
    Manufacturer
    3B MEDICAL INC.
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I PURCHASED A OXYGEN CONCENTRATOR FROM A BUSINESS CALLED (B)(6). THEY ARE SELLING SO CALLED REFURBISHED OXYGEN CONCENTRATOR, I PURCHASED IN MARCH, MY MACHINE STOPPED WORKING REACHED OUT TO THEM AND WAS PRETTY MUCH TOLD "OH WELL." I'M ON A FIXED INCOME I PURCHASED BECAUSE I CAN'T AFFORD TO LEASE A MACHINE. THESE COMPANIES ARE BUYING JUNK AND SELLING AS REFURBISHED. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227466 STRATUS 5 GENERATOR, OXYGEN, PORTABLE CAW 3B MEDICAL INC. STR1005

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Other