BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION AUTO CPAP

    MDR report key: 21468420 · Received February 26, 2025

    Report

    Report Number
    2518422-2025-102367
    Event Type
    Malfunction
    Date Received
    February 26, 2025
    Date of Event
    January 21, 2025
    Report Date
    January 15, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959426887
    PMA / PMN Number
    K131982
    Removal / Correction Number
    Z-1974-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED TO PROVIDE ADDITIONAL INFORMATION FROM THE MANUFACTURER'S FINAL INVESTIGATION FINDINGS AND TO INCLUDE THE RELATED CODING FIELDS AND DATE RECEIVED BY MFG. THE MANUFACTURER PREVIOUSLY REPORTED: "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 INDICATING THAT THE PATIENT HAD REGISTERED THEIR DEVICE FOR THE RECALL SEVERAL YEARS AGO BUT HAD NOT RECEIVED ANY FOLLOW-UP ON THE NEXT STEPS. THE PATIENT REPORTED CONCERNS NOT ONLY ABOUT THE SAFETY OF THE DEVICE BUT ALSO ABOUT THE PROLONGED WAIT FOR A REPLACEMENT OR REFUND. DESPITE NUMEROUS FOLLOW-UPS WITH PHILIPS OVER THE YEARS, THE PATIENT HAS YET TO RECEIVE A RESOLUTION AND NOW SUFFERS FROM CHRONIC RESPIRATORY ILLNESS. THERE HAVE BEEN NO REPORTS OF SERIOUS HARM, INJURY, OR MEDICAL INTERVENTION RELATED TO THIS MATTER. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE." THE PRODUCT ASSOCIATED WITH THIS COMPLAINT WAS NOT RETURNED TO THE MANUFACTURER. THIS REPORT IS BEING SENT TO CONCLUDE THAT NO FURTHER INVESTIGATION IS POSSIBLE. NO DEVICE HAS BEEN RETURNED. NO FURTHER EVALUATION IS POSSIBLE AT THIS TIME. MULTIPLE ATTEMPTS TO HAVE THE DEVICE RETURNED FOR EVALUATION AND INVESTIGATION WERE UNSUCCESSFUL. IN ADDITION, CAPA PR 7211 DOCUMENTS THE INVESTIGATION INTO SIMILAR COMPLAINTS, CORRECTION/REMOVAL ACTIVITIES HAVE BEEN INITIATED (REFER TO H.9), AND COMPLAINT CODE TRENDING IS REVIEWED ON A PERIODIC BASIS TO EVALUATE FIELD QUALITY PERFORMANCE, AND AS AN INPUT TO RISK MANAGEMENT ACTIVITIES.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED TO PROVIDE ADDITIONAL INFORMATION FROM THE MANUFACTURER'S FINAL INVESTIGATION FINDINGS AND TO INCLUDE THE RELATED CODING FIELDS AND DATE RECEIVED BY MFG. THE MANUFACTURER PREVIOUSLY REPORTED: "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 INDICATING THAT THE PATIENT HAD REGISTERED THEIR DEVICE FOR THE RECALL SEVERAL YEARS AGO BUT HAD NOT RECEIVED ANY FOLLOW-UP ON THE NEXT STEPS. THE PATIENT REPORTED CONCERNS NOT ONLY ABOUT THE SAFETY OF THE DEVICE BUT ALSO ABOUT THE PROLONGED WAIT FOR A REPLACEMENT OR REFUND. DESPITE NUMEROUS FOLLOW-UPS WITH PHILIPS OVER THE YEARS, THE PATIENT HAS YET TO RECEIVE A RESOLUTION AND NOW SUFFERS FROM CHRONIC RESPIRATORY ILLNESS. THERE HAVE BEEN NO REPORTS OF SERIOUS HARM, INJURY, OR MEDICAL INTERVENTION RELATED TO THIS MATTER. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE." THE PRODUCT ASSOCIATED WITH THIS COMPLAINT WAS NOT RETURNED TO THE MANUFACTURER. THIS REPORT IS BEING SENT TO CONCLUDE THAT NO FURTHER INVESTIGATION IS POSSIBLE. NO DEVICE HAS BEEN RETURNED. NO FURTHER EVALUATION IS POSSIBLE AT THIS TIME. MULTIPLE ATTEMPTS TO HAVE THE DEVICE RETURNED FOR EVALUATION AND INVESTIGATION WERE UNSUCCESSFUL. IN ADDITION, CAPA PR 7211 DOCUMENTS THE INVESTIGATION INTO SIMILAR COMPLAINTS, CORRECTION/REMOVAL ACTIVITIES HAVE BEEN INITIATED (REFER TO H.9), AND COMPLAINT CODE TRENDING IS REVIEWED ON A PERIODIC BASIS TO EVALUATE FIELD QUALITY PERFORMANCE, AND AS AN INPUT TO RISK MANAGEMENT ACTIVITIES.

    Description of Event or Problem · 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 RECEIVED INFORMATION INDICATING THAT THE PATIENT HAD REGISTERED THEIR DEVICE FOR THE RECALL SEVERAL YEARS AGO BUT HAD NOT RECEIVED ANY FOLLOW-UP ON THE NEXT STEPS. THE PATIENT REPORTED CONCERNS NOT ONLY ABOUT THE SAFETY OF THE DEVICE BUT ALSO ABOUT THE PROLONGED WAIT FOR A REPLACEMENT OR REFUND. DESPITE NUMEROUS FOLLOW-UPS WITH PHILIPS OVER THE YEARS, THE PATIENT HAS YET TO RECEIVE A RESOLUTION AND NOW SUFFERS FROM CHRONIC RESPIRATORY ILLNESS. THERE HAVE BEEN NO REPORTS OF SERIOUS HARM, INJURY, OR MEDICAL INTERVENTION RELATED TO THIS MATTER. 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
    659111 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. CAX500T12 00606959426887

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown