BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DS2ADV AUTO CPAP

    MDR report key: 20401081 · Received October 8, 2024

    Report

    Report Number
    2518422-2024-61316
    Event Type
    Malfunction
    Date Received
    October 8, 2024
    Date of Event
    July 18, 2024
    Report Date
    October 17, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959062733
    PMA / PMN Number
    K200480
    Removal / Correction Number
    Z-1974-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION REGARDING THE EQUIPMENT DATA: PRODUCT BRAND NAME: DS2ADV AUTO CPAP. MODEL NUMBER: DSX520H11C. CATALOG ITEM IDENTIFIER: DSX520H11C. SERIAL NUMBER: (B)(6). PRODUCT UDI: (B)(4). 510K: K200480. DEVICE PROBLEM CODE GRID: ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM REMEDIAL ACTION UNIT: NOT APPLICABLE. RECALL Z NUMBER: NOT APPLICABLE.

    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.

    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 PATIENT HAS SEVERAL ISSUES BREATHING WITH THE DEVICE. THERE WAS NO REPORT OF MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION CAN BE REQUESTED AT THIS TIME. 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
    21910 DS2ADV AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX520H11C 00606959062733

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown