BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAMSTATION AUTO CPAP

    MDR report key: 14250836 · Received April 29, 2022

    Report

    Report Number
    2518422-2022-16263
    Event Type
    Injury
    Date Received
    April 29, 2022
    Date of Event
    March 30, 2022
    Report Date
    August 16, 2024
    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

    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 RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT ALLEGED TO EXPERIENCE AFIB. THERE WAS NO MEDICAL INTERVENTION REQUIRED BY THE PATIENT. THE REPORTED EVENT OF AFIB 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. THE DEVICE HAS NOT YET RETURNED TO THE MANUFACTURER FOR EVALUATION AND AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED. SECTIONS 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.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY SUBMITTED MDR 2518422-2022-16263-1 WITH INCORRECT SECTIONS B1, B2, H1. CORRECTIONS TO PREVIOUS MDR ARE 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.

    Additional Manufacturer Narrative · 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 PREVIOUSLY RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT ALLEGED TO EXPERIENCE AFIB. THERE WAS NO MEDICAL INTERVENTION REQUIRED BY THE PATIENT. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S QUALITY PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION. THE MANUFACTURER USED A FITT (FOAM INTEGRITY TEST TOOL) AND WAS NOT ABLE TO CONFIRM THE PRESENCE OF DEGRADED SOUND ABATEMENT FOAM. IN SECONDARY FINDINGS MINOR DUST-LIKE AND FIBROUS CONTAMINATION AND OTHER UNKNOWN CONTAMINATION WAS OBSERVED ON AND AROUND THE ISO PORT. OBSERVED MINOR DUST-LIKE CONTAMINATION ON THE TOP ENCLOSURE UNDER THE RIGHT-SIDE ACCESSORY DOOR. THE BLOWER BOX AND BLOWER WERE VISUALLY FREE OF CONTAMINATION. THE DEVICE'S EVENT LOGS WERE DOWNLOADED AND REVIEWED BY THE MANUFACTURER. THE MANUFACTURER FOUND ONE ERROR CODES. THE MANUFACTURER CONCLUDES THAT UNABLE CONFIRM THE PRESENCE OF DEGRADED SOUND ABATEMENT FOAM. CONFIRMED THE PRESENCE OF MINOR CONTAMINATION, INCONSISTENT WITH DEGRADED SOUND ABATEMENT FOAM, ON THE DEVICE EXTERIOR. THERE IS NO VISIBLE DAMAGE OR FUNCTIONALITY FAILURES OF THE DEVICE, WHICH SUGGESTS THAT THE SOURCE OF CONTAMINATION WAS EXTERNAL TO THE DEVICE. SECTIONS D8, D9, H2, H3, AND H6 WERE UPDATED.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT ALLEGED AFIB FROM NOT USING THE DEVICE. MEDICAL INTERVENTION WAS NOT SPECIFIED. 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
    103861 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX500T11C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other