BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3B MEDICAL STRATUS 5 OXYGEN CONCENTRATOR

    MDR report key: 16487379 · Received March 2, 2023

    Report

    Report Number
    MW5115435
    Event Type
    Injury
    Date Received
    March 2, 2023
    Date of Event
    January 6, 2023
    Report Date
    February 28, 2023
    Manufacturer
    3B MEDICAL, INC.
    Product Code
    CAW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    HIS OXYGEN CONCENTRATOR WAS REPLACED. WITHIN 30 MIN HAD BURNING IN THE LUNGS AND DEVELOPED A MIGRAINE. WAS HURTING TO BREATH IN BOTH LUNGS. HE NOTICED THAT THERE WAS WHITE POWDER IN THE MACHINE. THE NEXT DAY HE HAD BODY ACHES AND JOINT PAINS. HAD ISSUES WITH JOINT PAIN AND SWELLING WITH REDNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705918 3B MEDICAL STRATUS 5 OXYGEN CONCENTRATOR GENERATOR, OXYGEN, PORTABLE CAW 3B MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Male Other