BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR AUTO

    MDR report key: 21262375 · Received January 29, 2025

    Report

    Report Number
    2518422-2025-009119
    Event Type
    Malfunction
    Date Received
    January 29, 2025
    Date of Event
    December 16, 2024
    Report Date
    January 7, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959005907
    PMA / PMN Number
    K131982
    Removal / Correction Number
    Z-1974-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR WAS PREVIOUSLY REPORTED UNDER MFR 2518422-2025-100268 AND IS THEREFORE A DUPLICATE.

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT REPORT TW (B)(4) (MDR 2518422-2025-009119) IS A DUPLICATE SUBMISSION OF MDR SUBMISSION OF (B)(4).

    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 VISUALIZATION OF PARTICLES. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE REQUESTED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808948 REMSTAR AUTO VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DS560TS 00606959005907

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown