BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS RESPIRONICS DREAMSTATION

    MDR report key: 19658232 · Received July 1, 2024

    Report

    Report Number
    MW5156910
    Event Type
    Injury
    Date Received
    July 1, 2024
    Date of Event
    June 1, 2021
    Report Date
    June 28, 2024
    Manufacturer
    PHILIPS CORPORATION/RESPIRONICS INC.
    Product Code
    BZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    YOU SIMPLY RECALL THESE MACHINES BECAUSE OF A DEFECT IN THE FOAM THAT INSULATED THE MOTOR. THE MEDICAL OFFICE I WAS GOING TO INFORM ME THAT MY EKG CAME BACK ABNORMAL BUT WAS GOING TO REQUIRE SOME VERY EXPENSIVE TESTS THAT MY INSURANCE WOULD NOT COVER AT THE TIME. AN ABNORMAL HEART RHYTHM WAS DISCOVERED. FURTHER TESTING AT THE TIME WAS PROHIBITIVELY EXPENSIVE. THE PHILIPS RESPIRONICS MACHINE THAT I WAS USING WAS RECALLED. THE LEGAL REPRESENTATION I ACQUIRED DID A TERRIBLE JOB AT REPRESENTING THEIR CLIENTS. YOU THE FDA DID A TERRIBLE JOB OF REPRESENTING THE PATIENTS WHO USE THIS MACHINE. I DO NOT BELIEVE I HAVE BEEN ADEQUATELY TESTED TO DETERMINE WHAT EFFECT THE MACHINE AND ITS DEFECTS HAD ON MY HEART HEALTH. I HAVE NOT EVEN BEEN ABLE TO GET A BASIC REFUND ON THE TWO MACHINES THAT I BOUGHT FROM PHILLIPS CORPORATION. I FEEL THAT THIS AGENCY WHICH IS SUPPOSED TO WORK FOR MY PROTECTION AND BENEFIT HAS FAILED TO DO SO. REFERENCE REPORT: MW5156909.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472868 PHILIPS RESPIRONICS DREAMSTATION VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILIPS CORPORATION/RESPIRONICS INC. DSX200S11

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male BLOOD PRESSURE MEDICATION.