BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAMSTATION AUTO CPAP

    MDR report key: 12652670 · Received October 18, 2021

    Report

    Report Number
    2518422-2021-05277
    Event Type
    Injury
    Date Received
    October 18, 2021
    Date of Event
    August 17, 2021
    Report Date
    September 1, 2023
    Manufacturer
    RESPIRONICS,INC
    Product Code
    BZD
    UDI-DI
    00606959034532
    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 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 PREVIOUSLY REPORTED AN ISSUE RELATED TO CPAP DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED THE PATIENT TO EXPERIENCE NASAL/THROAT IRRITATION, RESPIRATORY INFECTION, DIZZINESS AND DIFFICULTY BREATHING. THE PATIENT DID RECEIVE MEDICAL INTERVENTION IN THE FORM OF ANTIBIOTICS. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S QUALITY PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION. THE MANUFACTURER VISUALLY INSPECTED THE EXTERNAL PART OF THE DEVICE AND WHITE CONTAMINATE WAS FOUND ON THE FRONT PANEL OF THE DEVICE. THE MANUFACTURER VISUALLY INSPECTED THE DEVICE INTERNALLY AND FOUND DUST/DIRT CONTAMINATION ON THE OUTSIDE OF THE BLOWER BOX AND WATER INGRESS WITHIN THE BLOWER BOX AND BLOWER MOTOR. THE DEVICE'S EVENT LOGS WERE DOWNLOADED AND REVIEWED BY MANUFACTURER. THE MANUFACTURER FOUND NO ERROR CODES. THE MANUFACTURER APPLIED POWER TO THE DEVICE AND VERIFIED AIRFLOW. THE MANUFACTURER CONCLUDES THERE WAS EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION, BUT WATER INGRESS AND PRESENCE OF WHITE CONTAMINATE WERE OBSERVED AND ARE CONSISTENT WITH BEING FROM AN EXTERNAL SOURCE. SECTION H6 WERE UPDATED IN THIS REPORT.

    Additional Manufacturer Narrative · 0

    IN THE PREVIUS FOLLOW-UP REPORT (MDR 2518422-2021-05277-1), SECTION H6 WAS INCORRECTLY CAPTURED, IT HAS BEEN CORRECTED IN THIS REPORT TO REFLECT THE CORRECT INFORMATION.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A CPAP DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED THE PATIENT TO EXPERIENCE NASAL/THROAT IRRITATION, RESPIRATORY INFECTION, DIZZINESS AND DIFFICULTY BREATHING. THE PATIENT DID RECEIVE MEDICAL INTERVENTION IN THE FORM OF ANTIBIOTICS. 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
    1546273 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS,INC CAX500H12C 00606959034532

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| O