BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DORMA 500 AUTO

    MDR report key: 18279364 · Received December 6, 2023

    Report

    Report Number
    2518422-2023-34028
    Event Type
    Injury
    Date Received
    December 6, 2023
    Date of Event
    August 3, 2022
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959040410
    PMA / PMN Number
    K130077
    Removal / Correction Number
    Z-1974-2021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE NOT RETURNED TO 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 OF A PHYSICAL EXAMINATION IN THE FIRST HALF OF LAST YEAR WHERE ONE TUMOR INDEX ROSE. MEDICAL INTERVENTION WAS NOT SPECIFIED. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. THE MANUFACTURER BELIEVES THEY WILL BE UNABLE TO GATHER ADDITIONAL INFORMATION. THE MANUFACTURER IS SUBMITTING A FINAL REPORT AT THIS TIME. IF PERTINENT INFORMATION BECOMES AVAILABLE TO THE MANUFACTURER AT A LATER DATE, AN ADDENDUM TO THIS FINAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730602 DORMA 500 AUTO VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. CNV507HN1 00606959040410

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening