BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION2 ADVANCE AUTO CPAP

    MDR report key: 17485837 · Received August 9, 2023

    Report

    Report Number
    2518422-2023-18983
    Event Type
    Malfunction
    Date Received
    August 9, 2023
    Date of Event
    October 14, 2021
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K200480
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE DREAMSTATION 2 ADVANCED AUTO CPAP WHILE USING THE DEVICE SMOKE IS COMING FROM THE BACK LEFT OF THE DEVICE HOUSING. PATIENT STATES THAT SMOKE IS FINDING IT'S WAY INTO THE AIR INLET OF THE DEVICE. THE SMOKE THEN TRAVELS THROUGH THE TUBING AND INTO THE PATIENT'S MOUTH. SMOKE COMING FROM THE HEATING PAD IN THE HUMIDIFIER. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY FOR EVALUATION. THE TECHNICIAN OBSERVED THAT THE DEVICE UNDER SIDE OF THE HEATER PLATE HAD A 1 X 2-INCH ROUGH PATCH CONSISTENT WITH CHARRED EPOXY FROM THERMAL STRESS. HEATER PLATE SPRING HAD AN UNKNOWN BROWN STICKY SUBSTANCE IN APPROXIMATE LOCATION OF THE THERMAL EVENT OF THE HEATER PLATE. THE CPAP DEVICE, AND THE WATER TANK WAS FREE OF VISIBLE CONTAMINATION. THE TECHNICIAN PERFORMED AN EXTERNAL AND INTERNAL INSPECTION OF THE DEVICE AND OBSERVED THE FOLLOWING: CARE ORCHESTRATOR DATA WAS ABLE TO BE RETRIEVED, ONLY AFTER THE FIRMWARE OF THE DEVICE WAS UPDATED BY PIL TO V1.0.6.4326. THERE WAS 1 ERROR, E-178 (ERR_BT_APP_RESET) ERROR LEVEL - CONTINUE ERROR LOG: 1 ERROR WAS LOGGED. SEE 310337548_EL ATTACHMENT FOR ERROR DETAILS OF THE DATE AND TIME. BLOWER HOURS: 459. THERAPY HOURS: 458.7. PHOTOS ATTACHED. RISK TAG (ER 2233162 V08) ASSOCIATED WITH THIS MODE OF FAILURE: FIRE02, IRRIT06. THE RESULTS OF THIS INVESTIGATION DO NOT IMPACT THE CALCULATED RISKS. RA THERAPY DEVICE WAS OPERATED (BLOWER/THERAPY) FOR APPROXIMATELY 30 MINUTES WITH A HUMIDIFIER SETTING OF 5; NO ISSUES WERE OBSERVED, AND NO ERRORS WERE GENERATED. THERE ARE CLEAR INDICATIONS OF RESIDUE AND DISCOLORATION ON THE HUMIDIFIER PLATE ASSEMBLY AND/OR THE HUMIDIFIER SPRING (LIKELY DUE TO A THERMAL EVENT, CONFIRMING THE COMPLAINT). CHARACTERISTICS OF RA HEATER PLATE ARE CONSISTENT WITH KNOWN FAILURE MODE IDENTIFIED IN SUNNY (MFR) HEATER PLATES. HEATER PLATE MFR (SUNNY) HAS IMPLEMENTED MANUFACTURING PROCESS CHANGES TO ADDRESS THIS ISSUE (AS OF 11/2020). REFERENCE ALM1074 FOR FURTHER DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1588625 DREAMSTATION2 ADVANCE AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX520T11C

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male