BEUDAMED
    FDA Adverse Event Death Summary report: N

    DREAMSTATION ST30 H/HT, CN-NB

    MDR report key: 12490570 · Received September 17, 2021

    Report

    Report Number
    2518422-2021-04129
    Event Type
    Death
    Date Received
    September 17, 2021
    Date of Event
    September 14, 2021
    Report Date
    September 17, 2021
    Manufacturer
    RESPIRONICS INC
    Product Code
    MNS
    PMA / PMN Number
    K102465
    Removal / Correction Number
    RES 88058
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED A PATIENT DEATH. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1387989 DREAMSTATION ST30 H/HT, CN-NB VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS INC CNX1030T17

    Patients

    Seq Age Sex Outcome Treatment
    1 Death