BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMSTAR PLUS C-FLEX

    MDR report key: 18244835 · Received December 1, 2023

    Report

    Report Number
    2518422-2023-32879
    Event Type
    Injury
    Date Received
    December 1, 2023
    Date of Event
    October 9, 2023
    Report Date
    November 4, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K091319
    Removal / Correction Number
    Z-1974-2021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED ON THIS DEVICE IN MDR 2518422-2025-002541. THIS REPORT WAS SUBMITTED AS A DUPLICATE REPORT OF THE PREVIOUSLY SUBMITTED REPORT.

    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 AND PATIENT ALLEGING OF EYE IRRITATION, NOSE IRRITATION, SKIN IRRITATION, RESPIRATORY TRACT IRRITATION, DIZZINESS, HEADACHE, HYPERSENSITIVITY, ASTHMA, INFLAMMATORY RESPONSE AND LUNG DISEASE. THE PATIENT DID NOT REPORT TO RECEIVE MEDICAL INTERVENTION. 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
    1452024 REMSTAR PLUS C-FLEX VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DS250S

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other