BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DS2ADV AUTO CPAP

    MDR report key: 19402104 · Received May 27, 2024

    Report

    Report Number
    2518422-2024-31622
    Event Type
    Injury
    Date Received
    May 27, 2024
    Date of Event
    October 9, 2023
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K200480
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT: DEVICE HAS NOT BEEN RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 0

    IN THE PREVIOUSLY SUBMITTED REPORT THE 510K NUMBER WAS INCORRECT. 510K NUMBER HAS BEEN CORRECTED IN THIS REPORT AS K200480.

    Description of Event or Problem · 0

    THE MANUFACTURER BECAME AWARE OF A DS2ADV AUTO CPAP DEVICE ALLEGING SYMPTOMS OF EYE IRRITATION, NOSE IRRITATION, SKIN IRRITATION, RESPIRATORY TRACT IRRITATION, DIZZINESS, HEADACHE, HYPERSENSITIVITY, NAUSEA, VOMITING, ASTHMA (NEW OR WORSENING), INFLAMMATORY RESPONSE, KIDNEY DISEASE/TOXICITY, LUNG DISEASE, ACUTE RESPIRATORY DISTRESS SYSTEM, RESPIRATORY FAILURE, BRONCHITIS, AND SPOT IN LUNG. MEDICAL INTERVENTION WAS NOT SPECIFIED BY THE PATIENT. DUE TO POTENTIAL LITIGATION SURROUNDING THIS CASE, NO FOLLOW-UP CAN BE PERFORMED AT THIS TIME. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308698 DS2ADV AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX520H11C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other