BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPAP MACHINE

    MDR report key: 19559750 · Received June 17, 2024

    Report

    Report Number
    MW5156355
    Event Type
    Injury
    Date Received
    June 17, 2024
    Date of Event
    January 20, 2020
    Report Date
    June 12, 2024
    Manufacturer
    PHILLIPS / RESPIRONICS INC.
    Product Code
    BZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I USED THE PHILLIPS (LATER RECALLED) CPAP. I CALLED THE COMPANY PRIOR TO ANY RECALL NOTICE TO LET THEM KNOW THERE WERE BLACK PARTICLES FLOATING INSIDE THE WATER CHAMBER. THEY SAID TO CONTINUE USING THE MACHINE AND THIS WAS SOMETIMES NORMAL. I WAS LATER DIAGNOSED WITH KIDNEY CANCER AND HAD A KIDNEY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1511859 CPAP MACHINE VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILLIPS / RESPIRONICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Hospitalization| S| L PRAZOSIN.