BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION AUTO CPAP

    MDR report key: 14620917 · Received June 7, 2022

    Report

    Report Number
    2518422-2022-34048
    Event Type
    Malfunction
    Date Received
    June 7, 2022
    Date of Event
    August 16, 2021
    Report Date
    February 28, 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
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER WAS PREVIOUSLY 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 CPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT ALLEGED ACUTE/CHRONIC ILD, DIZZINESS, SHORTNESS OF BREATH, AND COUGH WHILE USING THE DEVICE. MEDICAL INTERVENTION WAS NOT SPECIFIED. IN INITIAL REPORT SECTION B5 WAS INCOMPLETELY MENTIONED AND THE UPDATED SECTION B5 SHOULD BE- 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 VOLUNTARY MEDWATCH (MW5109138) ALLEGING AN ISSUE RELATED TO A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE. THE PATIENT ALLEGED ACUTE/CHRONIC ILD, DIZZINESS, SHORTNESS OF BREATH, AND COUGH WHILE USING THE DEVICE. MEDICAL INTERVENTION WAS NOT SPECIFIED. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION. AN EXTERNAL VISUAL INSPECTION OF THE DEVICE WAS COMPLETED BY THE MANUFACTURER AND FOUND NO EVIDENCE OF CONTAMINATION. THE MANUFACTURER COMPLETED AN INTERNAL VISUAL INSPECTION. THE MANUFACTURER FOUND EVIDENCE OF WATER INGRESS AND CONTAMINATION IN BLOWER BOX, ON THE BLOWER AND IN THE WATER TANK. THE MANUFACTURER FOUND NO EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION. THE DEVICE'S DOWNLOADED EVENT LOG WAS REVIEWED BY THE MANUFACTURER AND FOUND E-4 ERROR LOGGED. THE DEVICE WAS APPLIED POWER AND THE DEVICE OPERATED PROPERLY. THE MANUFACTURER CONCLUDES THE CONTAMINATES FOUND WERE CONSISTENT WITH WATER INGRESS AND AN UNKNOWN CONTAMINANT, CONTAMINATION INCONSISTENT WITH THE SOUND ABATEMENT FOAM. THE MANUFACTURER CONFIRMED THERE WAS NO EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION. AFTER FURTHER REVIEW, THE MANUFACTURER CONFIRMED THAT THE PREVIOUSLY SUBMITTED REPORT WAS INCORRECTLY FILED AS ADVERSE EVENT WHICH SHOULD HAVE BEEN FILED AS PRODUCT PROBLEM ONLY. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    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 ACUTE/CHRONIC ILD, DIZZINESS, SHORTNESS OF BREATH, AND COUGH WHILE 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
    1142411 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX500H11C

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other HUMIDIFIRE DSXHCP (SN-(B)(6)).