BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REP DREAMSTATION AVAPS30

    MDR report key: 18714831 · Received February 15, 2024

    Report

    Report Number
    2518422-2024-07677
    Event Type
    Injury
    Date Received
    February 15, 2024
    Date of Event
    November 2, 2022
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNS
    PMA / PMN Number
    K102465
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A REP DREAMSTATION AVAPS DEVICE. THE MANUFACTURER RECEIVED INFORMATION FROM THE PATIENT ALLEGING THAT THE PATIENT HAS APNEA, SEIZURE, NOT BREATHING DEEPLY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310065 REP DREAMSTATION AVAPS30 VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS, INC. DSX1130S11F

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other