BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOCLEAN 2 CPAP CLEANER

    MDR report key: 9971720 · Received April 16, 2020

    Report

    Report Number
    MW5094171
    Event Type
    Malfunction
    Date Received
    April 16, 2020
    Date of Event
    February 15, 2020
    Report Date
    April 14, 2020
    Manufacturer
    SOCLEAN INC
    Product Code
    LRJ
    UDI-DI
    00187293000860
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS USING SOCLEAN 2 FOR MY CPAP AND STARTED TO NOTICE CHARCOAL LIKE RESIDUE IN MY WATER CHAMBER. I ASKED MY CPAP SUPPLIER ABOUT IT AND THEY ASKED IF I USED ANY CLEANING DEVICE AND TOLD THEM I WAS USING SOCLEAN 2. THEY INSTRUCTED ME TO STOP. I HAVE A RESMED MACHINE AND THEY TOLD ME THAT RESMED WILL NOT HONOR WARRANTY ON ANY EQUIPMENT THAT WAS PURCHASED AS OF 2-20 AND CLEANED WITH SOCLEAN. I HAVE HAD MY MACHINE FOR A COUPLE OF YEARS SO WILL BE COVERED IF NEED BE BUT THEY ADVISED ME TO STOP USING THE SOCLEAN 2 WHICH I DID IMMEDIATELY. FDA SAFETY REPORT ID #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434136 SOCLEAN 2 CPAP CLEANER DISINFECTANT, MEDICAL DEVICES LRJ SOCLEAN INC 00187293000860

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR