BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAMSTATION CPAP

    MDR report key: 21112468 · Received January 9, 2025

    Report

    Report Number
    2518422-2025-001237
    Event Type
    Injury
    Date Received
    January 9, 2025
    Date of Event
    October 9, 2023
    Report Date
    January 29, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K131982
    Removal / Correction Number
    Z-1974-2021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE NO DEVICE INFORMATION WAS PROVIDED, THE EXACT RECALL NUMBER IS UNKNOWN. POSSIBLE RECALL NUMBERS INCLUDE Z-1972-2021, Z-1973-2021, AND Z-1974-2021.

    Additional Manufacturer Narrative · 0

    IN PREVIOUS REPORT BOX C MANUFACTURING SITE CAPTURED AS RESPIRONICS,INC 6501 NOW ITS UPDATED TO RESPIRONICS,INC 1001 .

    Additional Manufacturer Narrative · 0

    IN PREVIOUS LEGACY COMPLAINT ID WAS BLANK NOW IT WAS UPDATED.

    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 ALLEGING EYE IRRITATION, NOSE IRRITATION, SKIN IRRITATION, RESPIRATORY TRACT IRRITATION, DIZZINESS AND/OR HEADACHE, ASTHMA (NEW OR WORSENING) AND REDUCED CARDIOPULMONARY RESERVE. THERE WAS NO REPORT OF MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION CAN BE REQUESTED AT THIS TIME. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE REQUESTED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367389 DREAMSTATION CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other