BEUDAMED
    FDA Adverse Event Death Summary report: N

    REP DREAMSTATION AVAPS30

    MDR report key: 20926202 · Received December 13, 2024

    Report

    Report Number
    2518422-2024-074423
    Event Type
    Death
    Date Received
    December 13, 2024
    Date of Event
    October 4, 2023
    Report Date
    December 13, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959063457
    PMA / PMN Number
    K131982
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE MANUFACTURER BECAME AWARE THAT A USER OF THE REP DREAMSTATION AVAPS30 HAD STATES DEATH OF THE PATIENT. NO MEDICAL INTERVENTION WAS SPECIFIED BY THE PATIENT. NO ADDITIONAL INFORMATION CAN BE REQUESTED AT THIS TIME. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. 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
    2415686 REP DREAMSTATION AVAPS30 VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX1130S11F 00606959063457

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death