BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR AUTOA-FLEX

    MDR report key: 21231550 · Received January 24, 2025

    Report

    Report Number
    2518422-2025-008009
    Event Type
    Malfunction
    Date Received
    January 24, 2025
    Date of Event
    August 29, 2022
    Report Date
    January 24, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959005891
    PMA / PMN Number
    K131982
    Removal / Correction Number
    Z-1974-2021
    Product Problem
    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 REMSTAR AUTOA-FLE DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGED VISUALIZATION OF PARTICLES. THERE WAS NO REPORT OF SERIOUS OR PERMANENT HARM OR INJURY. A DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER FOR EVALUATION. DURING THE EVALUATION OF THE DEVICE AT THE THIRD PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND VISIBLE FOAM PARTICLES WERE OBSERVED. 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
    1464783 REMSTAR AUTOA-FLEX VENTILATOR, NON-CONTINUOUS (RESPIR ATOR) BZD RESPIRONICS, INC. DS560HS DS560HS 00606959005891

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown