BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION GO W/BT, AUS

    MDR report key: 12585669 · Received October 6, 2021

    Report

    Report Number
    2518422-2021-04988
    Event Type
    Malfunction
    Date Received
    October 6, 2021
    Date of Event
    June 24, 2021
    Report Date
    December 16, 2024
    Manufacturer
    RESPORINOC INC
    Product Code
    BZD
    UDI-DI
    00606959044432
    PMA / PMN Number
    K131982
    Removal / Correction Number
    RES 88058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION B5 WAS CAPTURED INCORRECTLY IN PREVIOUS REPORT, IT SHOULD BE REPORTED AS FOLLOWS: 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 MACHINE ON INITIAL START AIR FELT DUSTY, WHEN HUMIDIFIER WAS DRY BLACK PARTICLES WERE FOUND AT BOTTOM. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. NO DEVICE HAS BEEN RETURNED. NO FURTHER EVALUATION IS POSSIBLE AT THIS TIME. A FINAL REPORT IS BEING SUBMITTED. IF NEW INFORMATION BECOMES AVAILABLE THAT CHANGES THE OUTCOME OF THE INVESTIGATION AND ASSOCIATED MEDICAL DEVICE REPORTING A FOLLOW UP/SUPPLEMENTAL REPORT WILL BE COMPLETED. SECTION H6 CODES CAPTURED INCORRECTLY IN PREVIOUS REPORT, IT HAS BEEN CORRECTED AND UPDATED IN THIS REPORT.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO PATIENT HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1481582 DREAMSTATION GO W/BT, AUS VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPORINOC INC AUG400S15 00606959044432

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown