BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS RESPIRATORY CPAP MACHINE

    MDR report key: 13677704 · Received March 4, 2022

    Report

    Report Number
    MW5107898
    Event Type
    Injury
    Date Received
    March 4, 2022
    Date of Event
    January 1, 2020
    Report Date
    March 2, 2022
    Manufacturer
    PHILIPS/RESPIRONICS, INC.
    Product Code
    BZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I SAW BLACK SPECKS IN THE CPAP MACHINE I WAS USING. I WAS HAVING MORE ASTHMA PROBLEMS AND BAD SINUS REACTIONS. I THOUGHT SOMETHING WAS WRONG WITH THE CPAP. IN (B)(6) 2020 I WAS DIAGNOSED WITH A BACTERIA INFECTION WHICH LED TO HAVING MY BALLOON PUMP REMOVED. I GOT BACTERIAL PNEUMONIA AFTER THE SURGERY AND SPENT A WEEK IN THE HOSPITAL. IN (B)(6) 2019 I HAD X-RAYS PRIOR TO SURGERY AND THE RADIOLOGIST REPORTED NODULES IN MY LUNGS. EVERY X-RAY SINCE THE REPORT HAS NODULES IN MY LUNGS. IN (B)(6) 2020 I WAS DIAGNOSED WITH LVD HEART FAILURE AND COPD. I HAVE USED OXYGEN IN THE DAY OFF AND ON. I USE OXYGEN AT NIGHT WITH THE CPAP NOW. I DIDN'T NEED OXYGEN BEFORE THIS. (B)(6) 2020 I WAS DIAGNOSED WITH SEPTAKE LYMPH NODES AND STREP THROAT. ALL OF THIS HAS HAPPENED AFTER I HAD TROUBLE WITH THE CPAP AND SAW THE BLACK PIECES IN THE CPAP. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2116208 PHILIPS RESPIRATORY CPAP MACHINE VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILIPS/RESPIRONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Hospitalization| S