BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DS2ADV AUTO CPAP W/HUMID

    MDR report key: 24702166 · Received March 26, 2026

    Report

    Report Number
    2518422-2026-010060
    Event Type
    Malfunction
    Date Received
    March 26, 2026
    Date of Event
    December 12, 2024
    Report Date
    April 1, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959075634
    PMA / PMN Number
    K200480
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED AN END USER ALLEGING THE DEVICE WAS OVERHEATING, WITNESSED PUFFS OF SMOKE, POWERING OFF RANDOMLY DURING THE NIGHT, INTERMITTENT OPERATION, AND A BURNING ELECTRICAL ODOR. THE DEVICE WAS RETURNED TO THE MANUFACTURER¿S PRODUCT INVESTIGATION LAB (PIL) FOR ADDITIONAL TESTING AND INVESTIGATION. DURING THE EVALUATION OF THE DEVICE, PIL CONFIRMED THE DEVICE POWERS ON, PROVIDES AIRFLOW, THE HEATED TUBE HEATS, AND THE HEATER PLATE HEATS. ERROR CODES E-93 (ERR_RTC_VALUE), A CONTINUE ERROR, E-15 (ERR_CYCLE_HANDLER_OVERRUN), A REBOOT ERROR, E-203 (ERR_RTOS_NO_MESSAGE_AVAILABLE)<(>,<)> A REBOOT ERROR, E-100 (ERR_HUMID_NO_HEAT), A CONTINUE ERROR, E-176 (ERR_BT_RADIO_BIST_FAIL), A CONTINUE ERROR, E-87 (ERR_FLOW_SENSOR_BUS), A CONTINUE ERROR, E-83 (ERR_FSENS_UNABLE_TO_OBTAIN_BUS), A REBOOT ERROR, E-20 (ERR_MOTOR_SPINUP_FLUX_LOW), A REBOOT ERROR AND (ERR_MOTOR_SPEED_REVERSE), A REBOOT ERROR WAS PRESENT. A HEAT TEST WAS PERFORMED ON THE DEVICE AND HEATER PLATE TO VERIFY THAT THE TEMPERATURES WERE WITHIN THE REQUIRED PERIMETERS REQUIRED PER PRD 2300232 (V17) AND LBL 1143533 (V02). THE TEST RESULTS SHOWED THAT THE DEVICE AND HEATER PLATE RECORDED TEMPERATURES WITHIN THE THRESHOLD REQUIRED DURING THE 2 ½ HOUR TEST. A DUST-LIKE CONTAMINANT WAS OBSERVED ON THE UI DISPLAY BEZEL, TOP ENCLOSURE, CENTER ENCLOSURE, ISO PORT, INLET/OUTLET SEAL, BLOWER BOX CAP, INSIDE THE INLET OF THE BLOWER BOX, ON THE BLOWER, BLOWER SEAL BLOWER BOX, HEATER PLATE, HEATER PLATE SPRING, AND BOTTOM ENCLOSURE. WHAT APPEARED TO BE DRIED LIQUID SPOTS WITH POTENTIAL MINERAL DEPOSITS WERE OBSERVED ON THE UI DISPLAY BEZEL, TOP ENCLOSURE, CENTER ENCLOSURE, ISO PORT, PCA, INLET/OUTLET SEAL, BLOWER BOX CAP, INSIDE THE INLET OF THE BLOWER BOX, ON THE BLOWER, BLOWER SEAL BLOWER BOX, HEATER PLATE, HEATER PLATE SPRING, AND BOTTOM ENCLOSURE. HAIR-LIKE PARTICLES WERE OBSERVED ON THE BOTTOM ENCLOSURE. THE BRASS NUT OF THE BLOWER WAS OBSERVED TO HAVE POSSIBLE CORROSION TO IT, LIKELY DUE TO LIQUID INGRESS OF THE BLOWER AND THE PCA WAS OBSERVED TO HAVE POSSIBLE CORROSION TO IT LIKELY DUE TO LIQUID INGRESS TO IT. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 0

    THIS NOTIFICATION WAS REVIEWED DUE TO A PATIENT STATING THE UNIT IS OVERHEATING AND HAS WITNESSED "PUFFS" OF SMOKE FROM THE UNIT. PATIENT ALSO STATED UNIT IS POWERING OFF AT RANDOM DURING THE NIGHT. THE DEVICE HAS BEEN SENT TO THE MANUFACTURER¿S PRODUCT INVESTIGATION LAB (PIL) FOR ADDITIONAL TESTING AND INVESTIGATION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. 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
    2966 DS2ADV AUTO CPAP W/HUMID VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX520T11C 00606959075634

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male