BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILLIPS DREAM STATION

    MDR report key: 12137957 · Received July 7, 2021

    Report

    Report Number
    MW5102395
    Event Type
    Injury
    Date Received
    July 7, 2021
    Date of Event
    June 26, 2021
    Report Date
    July 2, 2021
    Manufacturer
    PHILLIPS / RESPIRONICS, INC.
    Product Code
    BZD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I PASSED OUT AT HOME DUE TO ISSUES FROM NOT USING MY CPAP MACHINE FOR 2 WEEKS DUE TO THE RECALL OF THE PHILLIPS DREAMMACHINE. I HAVE NOT BEEN SLEEPING WELL AND WAKE OFTEN TO FIND MYSELF NOT BREATHING. I THEN TAKE DEEP BREATHS UNTIL I CAN FALL ASLEEP AGAIN. THIS HAS BEEN TAKING PLACE FOR THE LAST 2 WEEKS SINCE THE RECALL. I HAVE TOLD MY CPAP DOCTOR THAT I NEED ANOTHER MACHINE SUCH AS THE RES -MED BUT HE DOES NOT RETURN MY CALLS. I ALSO TOLD MY PRIMARY CARE DOCTOR BUT SHE TOLD ME I HAVE TO HANDLE THE SITUATION WITH THE DOCTOR WHO GAVE ME THE PRESCRIPTION FOR MY ORIGINAL CPAP MACHINE. THE EMERGENCY ROOM DOCTOR DID SEND A MESSAGE TO MY DOCTOR BUT THE DOCTOR DID NOT RESPOND. I CAN PURCHASE A RES- MED CPAP FROM A MEDICAL SUPPLIES COMPANY BUT THEY COST AROUND (B)(6) AND I AM ON A FIXED INCOME AND CAN'T AFFORD IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1023040 PHILLIPS DREAM STATION VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILLIPS / RESPIRONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization