BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMIN CPAP CLEANER

    MDR report key: 12894194 · Received November 29, 2021

    Report

    Report Number
    MW5105668
    Event Type
    Injury
    Date Received
    November 29, 2021
    Report Date
    November 24, 2021
    Manufacturer
    3B MEDICAL INC.
    Product Code
    LRJ
    UDI-DI
    1778302040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    USED LUMIN CPAP MASK CLEANER, WHICH USES UV LIGHT TO SANITIZE SILICONE NASAL CUSHION FROM FACTORY SEALED DREAMWEAR NASAL CUSHION, OBSERVED SIGNIFICANT ODOR WHEN OPENED LUMIN CHAMBER. PREVIOUSLY READ THE ODOR WAS CAUSED BY IT BREAKING DOWN CONTAMINATES. THERE SHOULD NOT HAVE BEEN ANY CONTAMINATES ON FACTORY SEALED CUSHION. CONCERNED USING UV CLEANER ON NASAL CUSHION MAY CAUSE VOCS. FDA SAFETY REPORT IDS# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1786250 LUMIN CPAP CLEANER DISINFECTANT, MEDICAL DEVICES LRJ 3B MEDICAL INC. LM3000 1778302040
    1786251 DREAMWEAR UNDER THE NOSE NASAL CUSHION VENTILATOR, NON-CONTINUOUS (RESPIRATOR) LRJ PHILIPS / RESPIRONICS, INC. 1116742 0302177125 00606959402027

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male