BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAMSTATION AUTO BIPAP

    MDR report key: 18322616 · Received December 13, 2023

    Report

    Report Number
    2518422-2023-35337
    Event Type
    Injury
    Date Received
    December 13, 2023
    Date of Event
    October 9, 2023
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K131982
    Removal / Correction Number
    Z-1974-2021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MODEL NUMBER (1051158) AND SERIAL NUMBER ((B)(6)) REPORTED CORRESPONDS TO A HUMIDIFIER. BASE DEVICE IS UNKNOWN BUT HAS BEEN REPORTED AS A DREAMSTATION AUTO BIPAP, AS THIS IS THE MOST LIKELY CORRESPONDING PRODUCT. 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 THAT THE PATIENT REPORTED CANCER AND SMOLDERING MULTIPLE MYELOMA. MEDICAL INTERVENTION WAS NOT SPECIFIED. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION AND NO ADDITIONAL INFORMATION COULD BE RECEIVED DUE TO THE CUSTOMER SEEKING LEGAL REPRESENTATION. 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
    1980278 DREAMSTATION AUTO BIPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. 1051158

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other