BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOCLEAN

    MDR report key: 14513067 · Received May 25, 2022

    Report

    Report Number
    MW5109910
    Event Type
    Death
    Date Received
    May 25, 2022
    Date of Event
    October 14, 2020
    Report Date
    May 23, 2022
    Manufacturer
    SOCLEAN, INC.
    Product Code
    LRJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    MY HUSBAND USED THE PHILIPS DREAM STATION CPAP (HE BEGAN WITH IT ON (B)(6) 2018) WHICH WAS ON THE RECALL LIST. I IMMEDIATELY NOTIFIED PHILIPS BUT IT TOOK APPROXIMATELY A YEAR BEFORE HE RECEIVED A NEW MACHINE. HE HAD A HISTORY OF NONSMALL CELL LUNG CANCER WHICH WAS TREATED AND CURED. HE CONTINUED TO RECEIVE ANNUAL CHEST CT SCANS. IN (B)(6) 2020 HIS CT SCAN WAS SUSPICIOUS FOR CANCER AND A PT SCAN WAS DONE WHICH SHOWED EXTENSIVE CANCER AND WAS SUBSEQUENTLY DIAGNOSED WITH SMALL CELL LUNG CANCER. THE RECALL HAD BEEN STARTED BUT IT WAS ABOUT A YEAR LATER HE DID GET A NEW MACHINE WHICH WAS (B)(6) 2021. FOR THE ENTIRE YEAR OF 2021 HE DID RECEIVE TREATMENT FOR HIS SMALL CELL LUNG CANCER. MY HUSBAND DID USE THE SO CLEAN WITH HIS UNIT AND I EVEN QUESTIONED THE FDA ABOUT THIS BUT WAS GIVEN A VERY VAGUE ANSWER. HE STOPPED USING IT THE MINUTE WE HEARD ABOUT THE RECALL. HE COULD NOT GO WITHOUT HIS CPAP MACHINE SO AFTER CONSULTATION WITH HIS PULMONOLOGIST, HE CONTINUED TO USE UNTIL HE GOT HIS REPLACEMENT ABOUT A YEAR LATER. I CAN'T HELP BUT WONDER IF THAT IS WHY IS CANCER WAS SO EXTENSIVE WHEN HE HAD A NEGATIVE CHEST CT SCAN THE YEAR BEFORE. PHILIPS MADE US SHIP THE RECALLED MODEL BACK TO THEM. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2193860 SOCLEAN DISINFECTANT, MEDICAL DEVICES LRJ SOCLEAN, INC.
    2193861 PHILIPS DREAMSTATION VENTILATOR, NON-CONTINUOUS (RESPIRATOR) LRJ PHILIPS / RESPIRONICS, INC. DSX500H11C

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Hospitalization| D ALBUTEROL SUL 2.5MG/3 ML 1 AM | AMLODIPINE| ATEZOLIZUMAB EVERY 3 WEEKS UNTIL JAN. 2021| ATORVASTATIN| BEGAN FOUR 3 WEEK CYCLES OF ATEZOLIZUMAB, | CARBOPLATIN| CARBOPLATIN | DOCUSATE SODIUM| DULERA INHALER| ETOPOSIDE| ETOPOSIDE CYCLES| FISH OIL PILLS/OMEGA3| FLUTICASONE NASAL SPRAY| LOW DOSE ASPIRIN | OMEPRAZOLE| ON DAY 3 OF EACH CYCLE RECEIVES NEULASTA ONPRO| SPIRIVA RESPIMAT| VITAMIN D3| ZOLEDRONIC ACID TWO DOSES IN 2021