BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMSTAR AUTO A-FLEX

    MDR report key: 17805582 · Received September 25, 2023

    Report

    Report Number
    2518422-2023-24267
    Event Type
    Injury
    Date Received
    September 25, 2023
    Date of Event
    August 30, 2023
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959005884
    PMA / PMN Number
    K131982
    Removal / Correction Number
    Z-1974-2021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CHANGED BOX B: ADVERSE EVENT/PRODUCT PROBLEM. CHANGED BOX C: MANUFACTURING SITE. CHANGED BOX G: CONTACT OFFICE, CONTACT OFFICE ENTITY. CHANGED BOX H: IF FOLLOW UP, WHAT TYPE?, HEALTH IMPACT GRID.

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : DEVICE NOT RETURNED TO THE MANUFACTURER.

    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 EYE IRRITATION, NOSE IRRITATION, DIZZINESS, HEADACHE, SPOT ON THE LUNG, NECK PAIN. NO MEDICAL INTERVENTION WAS SPECIFIED BY THE PATIENT.  THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.   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
    1241663 REMSTAR AUTO A-FLEX VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DS560S 00606959005884

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other