BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REP DREAMSTATION ST30

    MDR report key: 22114329 · Received May 30, 2025

    Report

    Report Number
    2518422-2025-045668
    Event Type
    Injury
    Date Received
    May 30, 2025
    Date of Event
    October 12, 2023
    Report Date
    May 30, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNS
    UDI-DI
    00606959429741
    PMA / PMN Number
    K102465
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE MANUFACTURER WAS CONTACTED REP DREAMSTATION ST30, DS-RECRT. THE MANUFACTURER RECEIVED INFORMATION ALLEGING RESPIRATORY OTHER AND COPD. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTIONS WERE REPORTED. 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. DURING THE EVALUATION, SECONDARY FINDINGS WERE OBSERVED. 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 COULDN'T CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS NO VISIBLE FOAM DEGRADATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36672 REP DREAMSTATION ST30 VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS, INC. UDSX1030S11F 00606959429741

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other