BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DS2ADV AUTO CPAP

    MDR report key: 17937873 · Received October 16, 2023

    Report

    Report Number
    2518422-2023-26710
    Event Type
    Malfunction
    Date Received
    October 16, 2023
    Date of Event
    July 23, 2022
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K200480
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTIVE AND PREVENTATIVE ACTIONS HAVE BEEN OPENED BY THE MANUFACTURER TO ADDRESS THE WATER INGRESS IDENTIFIED UPON INVESTIGATION.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE DREAMSTATION 2 ADVANCED AUTO CPAP DEVICE HAS SMOKE CAME FROM THE SEAL THAT SEALS THE WATER CHAMBER. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY FOR EVALUATION. EXTERNAL AND INTERNAL INSPECTION OF THE DEVICE AND OBSERVED THE FOLLOWING: PIL COULD NOT RETRIEVE THE DEVICE BLOWER OR THERAPY HOURS NOR CARE ORCHESTRATOR DATA DUE TO THE DEVICE NOT POWERING ON. PIL THEN DISASSEMBLED THE DEVICE AND FOUND THERMAL DAMAGE ON THE PCA DUE TO WATER INGRESS. THIS IS A KNOWN ISSUE INVESTIGATED UNDER CAPA 1299367. PIL CONCLUDED THAT WATER INGRESS CAUSED THE THERMAL DAMAGE, WHICH IN TURN PRODUCED THE SMOKE. RISK TAGS (ER 2233162, REV 8) ASSOCIATED WITH THIS MODE OF FAILURE INCLUDE: FIRE02, FIRE04. THE RESULTS OF THIS INVESTIGATION DO NOT IMPACT THE CALCULATED RISKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1414573 DS2ADV AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX520H11C

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male