BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION AUTO CPAP W/HUM/HT/CELL,DOM

    MDR report key: 12447823 · Received September 9, 2021

    Report

    Report Number
    2518422-2021-03882
    Event Type
    Malfunction
    Date Received
    September 9, 2021
    Date of Event
    July 16, 2021
    Report Date
    July 6, 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
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MDR 2518422-2021-03882 IS THE ORIGINAL REPORT ASSOCIATED WITH THIS DEVICE. A DUPLICATE REPORT HAS BEEN SUBMITTED FOR THIS DEVICE UNDER REPORT MDR 2518422-2021-04049. THIS CORRECTION REPORT IS BEING FILED FOR AWARENESS OF THIS DUPLICATE REPORT. A CORRECTION REPORT 2518422-2021-04049-1 HAS BEEN FILED FOR AWARENESS ABOUT THE DUPLICATE REPORT.

    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 A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED A PATIENT DEVELOP RESPIRATORY ISSUES AND MUCOUS. THE REPORTED EVENT OF RESPIRATORY ISSUES, MUCOUS AND ITS REPORTED SEVERITY WAS REVIEWED BY THE MANUFACTURE'S CLINICAL EXPERT. THIS EVENT IS ASSESSED AS NOT RELATED TO THE DEVICE IN THIS CASE. BASED ON THE AVAILABLE INFORMATION, THE MANUFACTURE CONCLUDES NO FURTHER ACTION IS NECESSARY. THE MEDICAL INTERVENTION RECEIVED BY THE PATIENT IN THE FORM OF PRESCRIBED MEDICATION. THE DEVICE HAS NOT YET RETURNED TO THE MANUFACTURER FOR EVALUATION. HENCE, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, 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 · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED THE PATIENT TO DEVELOP RESPIRATORY ISSUES. THE PATIENT WAS PRESCRIBED MEDICATION IN RESPONSE TO THE REPORTED EVENT. 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
    1343554 DREAMSTATION AUTO CPAP W/HUM/HT/CELL,DOM VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX500T11C

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention