BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAMSTATION CPAP

    MDR report key: 19753980 · Received July 16, 2024

    Report

    Report Number
    2518422-2024-44650
    Event Type
    Injury
    Date Received
    July 16, 2024
    Date of Event
    January 3, 2023
    Report Date
    July 16, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K131982
    Removal / Correction Number
    Z-1974-2021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    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 AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGED THAT PATIENT WAS TOO SICK, AND HE NEEDED IT 1 1/2 YEARS AGO AND TOLD HE HAD IDIOPATHIC PULMONARY FIBROSIS (IPF), A SERIOUS LUNG CONDITION. PATIENT READINGS ARE PROBABLY NOT RIGHT NOW & HE'S NOT ABLE TO DO ANY TESTS RIGHT NOW. THE MANUFACTURE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURE'S INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2505214 DREAMSTATION CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX200H11

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other