BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DS2ADV AUTO CPAP

    MDR report key: 20373336 · Received October 4, 2024

    Report

    Report Number
    2518422-2024-101563
    Event Type
    Malfunction
    Date Received
    October 4, 2024
    Date of Event
    September 2, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959062733
    PMA / PMN Number
    K200480
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY RECEIVED AN ALLEGATION A DS2ADV AUTO CPAP DEVICE WAS SMOKING FROM THE SD PORT. THERE WAS NO REPORT OF FLAMES, MELTING, OR EXPOSED WIRES. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION. USING A KNOWN GOOD POWER SUPPLY AND POWER CORD, THE PRODUCT INVESTIGATION LAB WAS ABLE TO CONFIRM THE DEVICE POWERS ON, AND REBOOTS WHILE INITIATING THERAPY. REVIEW OF THE ERROR LOGS SHOWS THE DEVICE HAS 8640.1 BLOWER HOURS AND 7538.1 THERAPY HOURS. THERE WAS A TOTAL OF 18 ERRORS LOGGED. THESE ERRORS INCLUDE: 1 INSTANCE OF E-7 (ERR_SOFTWARE), A REBOOT ERROR; 4 INSTANCES OF E-15 (ERR_CYCLE_HANDLER_OVERRUN), A REBOOT ERROR; 1 INSTANCE OF E-71 (ERR_PSENS_STATUS_BITS_ERROR), A REBOOT ERROR; 4 INSTANCES OF E-83 (ERR_FSENS_UNABLE_TO_OBTAIN_BUS), A REBOOT ERROR; 1 INSTANCE OF E-93 (ERR_RTC_VALUE), A CONTINUE ERROR; 1 INSTANCE OF E-203 (ERR_RTOS_NO_MESSAGE_AVAILABLE), A REBOOT ERROR; 1 INSTANCE OF E-303 (ERR_TOUCH_SENSOR_COMS), A CONTINUE ERROR AND 5 INSTANCES OF E-250 (ERR_BAROMETRIC_COMM), A CONTINUE ERROR. CARE ORCHESTRATOR DATA WAS NOT AVAILABLE FOR DOWNLOAD. DURING THE INVESTIGATION, THE LAB OBSERVED THE FILTER APPEARED TO HAVE A DARK, DUSTY APPEARANCE TO IT. THE WATER TANK LID, WATER TANK SEAL, AND WATER TANK WERE ALL OBSERVED TO HAVE A DUST-LIKE CONTAMINANT ON THEM WITH WHAT APPEARED TO BE DRIED LIQUID SPOTS WITH POTENTIAL MINERAL DEPOSITS. AN UNKNOWN CONTAMINANT WAS OBSERVED ON THE WATER TANK PAN. A DUST-LIKE CONTAMINANT AND HAIR-LIKE PARTICLES WERE OBSERVED ON THE USER INTERFACE DISPLAY BEZEL, TOP ENCLOSURE, CENTER ENCLOSURE, AND ISO PORT. WHAT APPEARED TO BE BURN MARKS AND AN UNKNOWN CORROSION WERE OBSERVED ON THE USER INTERFACE DISPLAY BEZEL, USER INTERFACE RIBBON CABLE, AND ISO PORT, LIKELY DUE TO THERMAL DAMAGE ON THE PCA. WHAT APPEARED TO BE DRIED LIQUID SPOTS WITH POTENTIAL MINERAL DEPOSITS WERE OBSERVED ON THE TOP ENCLOSURE, CENTER ENCLOSURE, AND ISO PORT. THE Q3 AND Q4 COMPONENTS ON THE PCA WERE OBSERVED TO HAVE THERMAL DAMAGE, AND THE PCA WAS OBSERVED TO HAVE CORROSION TO IT, BOTH LIKELY DUE TO LIQUID INGRESS. WHAT APPEARED TO BE DRIED LIQUID SPOTS WITH POTENTIAL MINERAL DEPOSITS WERE ALSO OBSERVED ON THE PCA. THE ISSUE OF LIQUID INGRESS TO THE PCA HAS BEEN PREVIOUSLY INVESTIGATED AS DOCUMENTED IN CAPA 3376332. A DUST-LIKE CONTAMINANT WAS OBSERVED ON THE 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 HEATER PLATE, HEATER PLATE SPRING, AND BOTTOM ENCLOSURE. HAIR-LIKE PARTICLES WERE OBSERVED ON THE BOTTOM ENCLOSURE. THE PRODUCT INVESTIGATION LAB WAS NOT ABLE TO CONFIRM THE COMPLAINT OF DEVICE SMOKING BUT CAN CONFIRM THERMAL DAMAGE TO THE PCA. THE MANUFACTURER HAS UPDATED SECTION H IN THIS REPORT. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED AN ALLEGATION A DS2ADV AUTO CPAP DEVICE WAS SMOKING FROM THE SD PORT. THERE WAS NO REPORT OF FLAMES, MELTING, OR EXPOSED WIRES. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE DEVICE HAS BEEN RETURNED FOR EVALUATION, BUT THE INVESTIGATION IS NOT YET COMPLETE. 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
    1402122 DS2ADV AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX520H11C 00606959062733

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Unknown