BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAMSTATION BIPAP AUTOSV

    MDR report key: 20328025 · Received September 27, 2024

    Report

    Report Number
    2518422-2024-101196
    Event Type
    Injury
    Date Received
    September 27, 2024
    Date of Event
    August 1, 2022
    Report Date
    December 9, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNS
    UDI-DI
    00606959045385
    PMA / PMN Number
    K090539
    Removal / Correction Number
    Z-1973-2021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DURING INTERNAL REVIEW, IT WAS DETERMINED THAT A DUPLICATE REPORT WAS PREVIOUSLY SUBMITTED FOR THIS EVENT UNDER MFR 2518422-2024-101196. THAT SUBMISSION WAS ENTERED IN ERROR AND SHOULD NOT BE CONSIDERED A SEPARATE OR ADDITIONAL EVENT. THE CURRENT REPORT MFR 2518422-2021-04191 REFLECTS THE ACCURATE AND INTENDED SUBMISSION FOR THIS COMPLAINT. NO NEW INFORMATION OR NEW INCIDENT OCCURRED; THIS CORRECTION IS TO CLARIFY AND REMOVE THE UNINTENDED DUPLICATE REPORT.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING VISUALIZATION OF PARTICLES IN THE AIR PATH. THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE PATIENT WAS HOSPITALIZED FOR 10 DAYS AND WAS NOT ABLE TO BREATHE. IT IS UNKNOWN WHY THE PATIENT HAD A HARD TIME BREATHING. THE PATIENT REPORTS HAVING LOW OXYGEN AND COULDN'T SLEEP BECAUSE OF THE SLEEP APNEA. THE PATIENT REPORTS DRIVING OFF THE ROAD DUE TO FALLING ASLEEP. THE PATIENT REPORTS NODULES ON LUNGS, HAD TWO HEART ATTACKS WITH ONE MASSIVE HEART ATTACK OCCURRING TWO YEARS AGO. DUE TO THIS, THE PATIENT WENT INTO A COMA. THE PATIENT REPORTS THEY LOST EYESIGHT IN THEIR RIGHT EYE. THE PATIENT'S WHITE BLOOD CELL COUNT IS NOW 11 AND HAS CANCER. THE ALLEGATION OF CANCER WAS CAPTURED IN REPORT 2518422-2024-29095 THAT WAS PREVIOUSLY SUBMITTED. THE PATIENT REPORTED USING AN OZONE BASED DISINFECTION DEVICE 4 OR 5 YEARS AGO FOR 2 OR 3 MONTHS. THE PATIENT BELIEVES THE DEVICE IS QUIETLY KILLING HIM. THE PATIENT REPORTS THEY HAD FIVE PHILIPS DEVICES AND HAS TWO DEVICES NOW. ONE DEVICE WAS SENT BACK TO PERSANTE, ONE HE BELIEVES HE THREW AWAY AND HE DOES NOT KNOW WHO HAS THE THIRD ONE. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1739015 DREAMSTATION BIPAP AUTOSV VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS, INC. DSX900T11C 00606959045385

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Other| H