BEUDAMED
    FDA Adverse Event Death Summary report: N

    DREAMSTATION CPAP PRO

    MDR report key: 17951645 · Received October 17, 2023

    Report

    Report Number
    2518422-2023-26647
    Event Type
    Death
    Date Received
    October 17, 2023
    Date of Event
    September 18, 2023
    Report Date
    October 16, 2023
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K131982
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT OF A DREAMSTATION CPAP PRO PASSED AWAY. THE MANUFACTURER RECEIVED INFORMATION FROM A REPRESENTATIVE FROM QUINTE CPAP INC THAT THE DEVICE WAS RETURNED AND REPLACED, HOWEVER THE PATIENT IS DECEASED. NO FURTHER INFORMATION ABOUT THE PATIENT'S CAUSE OF DEATH COULD BE PROVIDED TO THE MANUFACTURER. THE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR INVESTIGATION. DURING THE EVALUATION OF THE DEVICE, THE THIRD-PARTY SERVICE CENTER VISUALLY INSPECTED THE DEVICE AND FOUND CALCIUM RESIDUE. THERE WAS NO EVIDENCE FOUND OF ANY FOAM PARTICLES DURING THE EVALUATION. THE DEVICE HAS BEEN SCRAPPED. 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
    1652838 DREAMSTATION CPAP PRO VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. CAX400H12

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death