BEUDAMED
    FDA Adverse Event Death Summary report: N

    REP DREAMSTATION AUTO BIPAP

    MDR report key: 19398170 · Received May 25, 2024

    Report

    Report Number
    2518422-2024-31329
    Event Type
    Death
    Date Received
    May 25, 2024
    Date of Event
    October 12, 2023
    Report Date
    August 11, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K131982
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : DEVICE RETURNED TO THIRD PARTY SERVICE CENTER FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER BECAME AWARE OF AN ALLEGATION THAT AN END USER DEVELOPED ASTHMA (NEW OR WORSENING), LUNG DISEASE, NOSE IRRITATION, SKIN IRRITATION, RESPIRATORY TRACT IRRITATION AND THERE WAS A REPORT OF PATIENT DEATH WHILE USING A REP DREAMSTATION AUTO BIPAP. THE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER. DURING EVALUATION OF THE DEVICE, THE THIRD-PARTY SERVICE CENTER VISUALLY INSPECTED THE DEVICE AND FOUND NO EVIDENCE OF FOAM PARTICLES OR DEGRADATION. THE DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR FURTHER EVALUATION. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTRE, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTRE. THERE WAS NO ERROR CODE FOUND. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THEY COULD CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS NO VISIBLE FOAM DEGRADATION AND UNIT GOT CORRECTED.

    Description of Event or Problem · 0

    THE MANUFACTURER BECAME AWARE OF AN ALLEGATION THAT AN END USER DEVELOPED ASTHMA (NEW OR WORSENING), LUNG DISEASE, NOSE IRRITATION, SKIN IRRITATION, RESPIRATORY TRACT IRRITATION AND THERE WAS A REPORT OF PATIENT DEATH WHILE USING A REP DREAMSTATION AUTO BIPAP. THE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER. DURING EVALUATION OF THE DEVICE, THE THIRD-PARTY SERVICE CENTER VISUALLY INSPECTED THE DEVICE AND FOUND NO EVIDENCE OF FOAM PARTICLES OR DEGRADATION. IN ADDITION, THE DEVICE PASSED THE FINAL TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658067 REP DREAMSTATION AUTO BIPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. UDSX700S11F

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death