BEUDAMED
    FDA Adverse Event Death Summary report: N

    PHILIPS CPAP

    MDR report key: 20122643 · Received September 3, 2024

    Report

    Report Number
    2518422-2024-55662
    Event Type
    Death
    Date Received
    September 3, 2024
    Date of Event
    May 25, 2023
    Report Date
    September 5, 2024
    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
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE DISREGARD THE ABOVE TW (B)(4) 2518422-2024-55662, IT IS DONE BY MISTAKE. THE FIRST INITIAL REPORT TW (B)(4) 2518422-2024-49835 IS THE CORRECT ONE.

    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 DEATH. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTIONS WERE REPOR TED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711756 PHILIPS CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death