BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DS2ADV AUTO CPAP

    MDR report key: 19868784 · Received July 30, 2024

    Report

    Report Number
    2518422-2024-48194
    Event Type
    Injury
    Date Received
    July 30, 2024
    Date of Event
    October 9, 2023
    Report Date
    January 13, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959062733
    PMA / PMN Number
    K200480
    Removal / Correction Number
    Z-1974-2021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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

    THE BELOW MENTIONED THINGS ARE CORRECTED AND UPDATED IN THIS REPORT. PRODUCT BRAND NAME WAS CORRECTED FROM PHILIPS CPAP TO DS2ADV AUTO CPAP. 510K WAS CORRECTED FROM K131982 TO K200480. MODEL NUMBER AND CATALOG ITEM IDENTIFIER WAS UPDATED DSX520H11C. SERIAL NUMBER WAS UPDATED (B)(6). PRODUCT UDI WAS UPDATED (B)(4). MANUFACTURE DATE WAS UPDATED 11/29/2021. REMEDIAL ACTION INIT WAS UPDATE FROM REQUIRED (RECALL) TO NOT APPLICABLE. RECALL (Z) NUMBER WAS UPDATE FROM REQUIRED (Z-1974-2021) TO NOT APPLICABLE.

    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 INFLAMMATORY RESPONSE, CANCER. MEDICAL INTERVENTION WAS NOT SPECIFIED. NO ADDITIONAL INFORMATION CAN BE REQUESTED AT THIS TIME. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. 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
    1734460 DS2ADV AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX520H11C 00606959062733

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other