BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOCLEAN 2 CPAP CLEANER

    MDR report key: 12814198 · Received November 12, 2021

    Report

    Report Number
    MW5105307
    Event Type
    Malfunction
    Date Received
    November 12, 2021
    Date of Event
    November 3, 2021
    Report Date
    November 9, 2021
    Manufacturer
    SOCLEAN, INC.
    Product Code
    LRJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    SINCE MY SLEEP APNEA DIAGNOSIS SOME YEARS AGO, I HAVE USED A CPAP MACHINE, CURRENTLY A RESMED AIRSENSE 10. IT'S HARD TO CLEAN (I HAVE PARKINSON'S DISEASE), SO I BOUGHT A SOCLEAN 2 SANITIZING DEVICE A FEW YEARS AGO. RECENTLY I NOTICED WHEN FILLING THE DISTILLED WATER RESERVOIR (WHICH I DO DAILY) THAT THERE WERE DARK GREEN PARTICLES OF VARIOUS SIZES IN THE WATER. I'M NOT SURE WHAT THEY WERE, BUT FOR ONE THING IT APPEARED THAT THE END OF THE TUBING THAT GOES INTO THE RESERVOIR HAD STARTED TO DISINTEGRATE. I CALLED SOCLEAN AND THEY WERE NO HELP AT ALL. THIS SEEMS DANGEROUS TO ME, SO I HAVE DISCONNECTED THE SOCLEAN DEVICE AND AM USING A NEW RESERVOIR. FDA NEEDS TO LOOK AT THESE DEVICES CAREFULLY AND GIVE US SOME GUIDANCE. THANKS. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1699834 SOCLEAN 2 CPAP CLEANER DISINFECTANT, MEDICAL DEVICES LRJ SOCLEAN, INC.
    1699838 VENTILATOR, NON-CONTINUOUS (RESPIRATOR) RESMED AIRSENSE LRJ RESMED CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female