BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAMSTATION BIPAP PRO

    MDR report key: 19915617 · Received August 6, 2024

    Report

    Report Number
    2518422-2024-48306
    Event Type
    Injury
    Date Received
    August 6, 2024
    Date of Event
    October 9, 2023
    Report Date
    January 10, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959051546
    PMA / PMN Number
    K131982
    Removal / Correction Number
    Z-1974-2021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: 510K: UPDATED TO K131982, 510K (RFB): REQUIRED, PRODUCT BRAND NAME: UPDATED TO DREAMSTATION BIPAP PRO, MODEL NUMBER (RFB): REQUIRED, MODEL NUMBER: UPDATED TO DSX600H11C, CATALOG ITEM IDENTIFIER (RFB): REQUIRED, CATALOG ITEM IDENTIFIER: UPDATED TO DSX600H11C, SERIAL NUMBER (RFB): REQUIRED, SERIAL NUMBER: UPDATED TO (B)(6), PRODUCT UDI (RFB): REQUIRED, PRODUCT UDI: UPDATED TO (B)(4), MANUFACTURE DATE: 8/20/2019, MANUFACTURE DATE (RFB): REQUIRED.

    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; ASTHMA (NEW OR WORSENING); KIDNEY DISEASE/TOXICITY AND REDUCED CARDIOPULMONARY RESERVE. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. 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
    1560854 DREAMSTATION BIPAP PRO ENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX600H11C 00606959051546

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other