BEUDAMED
    FDA Adverse Event Death Summary report: N

    PHILIPS CPAP DEVICE

    MDR report key: 16082500 · Received January 2, 2023

    Report

    Report Number
    2518422-2023-00005
    Event Type
    Death
    Date Received
    January 2, 2023
    Date of Event
    September 9, 2021
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K131982
    Removal / Correction Number
    RES 88058
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE HAS YET TO BE RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS A CORRECTION IN RESPONSE TO A DUPLICATE REPORT FILED IN ERROR UNDER MDR 2518422-2023-00005. PLEASE REFER TO (B)(4)/MDR 2518422-2023-103604, FOR ALL REPORTING PURPOSES.

    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 AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGED TO HAVING DEATH. 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
    1393342 PHILIPS CPAP DEVICE VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death