BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAMSTATION AUTO

    MDR report key: 14288810 · Received May 5, 2022

    Report

    Report Number
    2518422-2022-17017
    Event Type
    Injury
    Date Received
    May 5, 2022
    Date of Event
    June 1, 2021
    Report Date
    June 23, 2023
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K131982
    Removal / Correction Number
    RES 88058
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY SUBMITTED MDR 2518422-2022-17017-1 WITH INCORRECT SECTIONS B1, B2, H1, H6. CORRECTIONS TO PREVIOUS MDR WERE MADE IN THIS REPORT AS FOLLOWS. SECTION B1 WAS CORRECTED TO ADVERSE EVENT AND PRODUCT PROBLEM. (ONLY PRODUCT PROBLEM WAS CHECKED IN PREVIOUS MDR). SECTION B2 WAS CORRECTED TO OTHER SERIOUS OR IMPORTANT MEDICAL EVENTS. (PREVIOUSLY IT WAS BLANK). SECTION H1 WAS CHANGED FROM MALFUNCTION TO SERIOUS INJURY. SECTION H6 - HEALTH EFFECT - IMPACT CODE WAS UPDATED.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED AN ALLEGATION OF AN ISSUE RELATED TO SOUND ABATEMENT FOAM.   ADDITIONAL INFORMATION WAS RECEIVED AND SECTION B5 SHOULD BE REPORTED AS:   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 PREVIOUSLY RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGED LYMPHEDEMA, COUGHING, SARCOIDOSIS. THE REPORTED EVENT OF LYMPHEDEMA, COUGHING, SARCOIDOSIS AND ITS REPORTED SEVERITY WAS REVIEWED BY THE MANUFACTURER'S CLINICAL EXPERT. THIS EVENT IS ASSESSED AS NOT RELATED TO THE DEVICE IN THIS CASE. BASED ON THE AVAILABLE INFORMATION, THE MANUFACTURER CONCLUDES NO FURTHER ACTION IS NECESSARY. THERE WAS NO MEDICAL INTERVENTION REQUIRED BY THE PATIENT.   REPEATED ATTEMPTS TO HAVE THE DEVICE DETAILS, DEVICE AND COMPONENTS RETURNED FOR EVALUATION AND INVESTIGATION WERE UNSUCCESSFUL. THE MANUFACTURER BELIEVES THEY WILL BE UNABLE TO GATHER ADDITIONAL INFORMATION. THE MANUFACTURER IS SUBMITTING AN UPDATED REPORT AT THIS TIME. IF PERTINENT INFORMATION BECOMES AVAILABLE TO THE MANUFACTURER AT A LATER DATE, A FOLLOW-UP REPORT WILL BE FILED.   SECTION(S) B1, B2, HAS CHANGED RELATED TO THE COMPLAINT CHANGING FROM THE REPORTED ADVERSE EVENT TO A PRODUCT PROBLEM. SECTION H1 HAS CHANGED TO REFLECT A MALFUNCTION. SECTION H6 HEALTH EFFECT- IMPACT CODE, TYPE OF INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS HAS BEEN UPDATED.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP/BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT ALLEGES TO HAVE LYMPHEDEMA; COUGHING; SARCOIDOSIS. THERE IS NO REPORT OF MEDICAL INTERVENTION BEING REQUIRED. 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
    1046280 DREAMSTATION AUTO VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other