BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION GO W/BT

    MDR report key: 12095815 · Received June 30, 2021

    Report

    Report Number
    2518422-2021-02021
    Event Type
    Malfunction
    Date Received
    June 30, 2021
    Date of Event
    June 25, 2021
    Report Date
    December 19, 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

    THE MANUFACTURER PREVIOUSLY REPORTED AN ISSUE RELATED TO SOUND ABATE FOAM. THIS ACTION WAS REPORTED TO FDA PER 21 CF1 PART 806. THE DEVICE WILL BE CORRECTED PER RES 88058.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. 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 REPORT OF PATIENT HARM OR INJURY. 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
    987309 DREAMSTATION GO W/BT VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPORINOC INC AUG400S15 00606959044432

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown