BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAMSTATION GO AUTO

    MDR report key: 19435103 · Received May 31, 2024

    Report

    Report Number
    2518422-2024-33091
    Event Type
    Injury
    Date Received
    May 31, 2024
    Date of Event
    October 9, 2023
    Report Date
    May 5, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K131982
    Removal / Correction Number
    Z-1974-2021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE/RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION THAT THE PATIENT ALLEGING KIDNEY DISEASE/TOXICITY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S QUALITY PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION. THE MANUFACTURE QUALITY PRODUCT INVESTIGATION LABORATORY INVESTIGATED THERAPY WITH THE DEVICE AND VERIFIED AIRFLOW, USING A PIL SUPPLIED AC POWER CORD. PIL USED A PIL SUPPLIED 12MM TUBE FOR TESTING. PIL ATTACHED A KNOWN GOOD HUMIDIFIER (ETF 3100908-006) AND VERIFIED AIRFLOW AND VERIFIED THAT THE HEATER PLATE BECAME WARM. PIL ATTACHED A PIL SUPPLIED KNOWN GOOD BATTERY PACK AND VERIFIED AIRFLOW AND THAT THE DEVICE OPERATES WITH A BATTERY PACK. PIL WAS NOT ABLE TO CONFIRM THE PRESENCE OF DEGRADED SOUND ABATEMENT FOAM IN THE DEVICE. THE MANUFACTURER CONCLUDES THERE WAS SECONDARY FINDINGS WERE OBSERVED AS 1 ERROR WAS LOGGED. PIL OBSERVED THE FOLLOWING FROM AN EXTERNAL AND INTERNAL INSPECTION: MISSING MICROSD AND USB COVER. DUST-LIKE CONTAMINATION AND TINY HAIRS/FIBERS IN AND OUTSIDE OF THE AIR OUTLET PORT. DUST-LIKE CONTAMINATION AND TINY HAIRS/FIBERS IN THE AIR INLET AND AREA NEAR THE AIR FILTER. ISO PORT HAD POTENTIAL MINERAL DEPOSIT STAINS INSIDE OF IT. ISO PORT COVER HAD DUST-LIKE CONTAMINATION INSIDE OF IT. AC POWER CONNECTOR COVER HAD DUST-LIKE CONTAMINATION AND HAIRS/FIBERS IN IT. INSIDE OF ENCLOSURE LID HAD A LIGHT UNKNOWN GRAY RESIDUE IN IT. PCA HAD POTENTIAL FLUX STAINS NEAR C143 AND NEAR C246 AND C247 PCA HAD LIGHT DUST-LIKE CONTAMINATION ON BOTTOM OF IT. POWER SUPPLY COVER HAD UNKNOWN GRAY RESIDUE STAINS ON IT AND TINY FIBERS/HAIRS ON IT. UNKNOWN GRAY RESIDUE STAINS ON THE BOTTOM ENCLOSURE AND DUST-LIKE CONTAMINATION WITH HAIRS/FIBERS. AIR INLET BAFFLE HAD DUST-LIKE CONTAMINATION AND TINY HAIRS/FIBERS ON IT. AIR INLET AREA NEAR THE AIR FILTER HAD DUST-LIKE CONTAMINATION AND HAIRS/FIBERS. WHITE AND BLACK DUST-LIKE CONTAMINATION, INCONSISTENT WITH SOUND ABATEMENT FOAM, AND SOME TINY BLACK HAIRS/FIBERS IN THE BOTTOM OF THE BLOWER BOX. PIL USED A FITT (FOAM INTEGRITY TEST TOOL) TO PROBE THE SOUND ABATEMENT FOAM, THAT WAS REACHABLE, AND WAS NOT ABLE TO CONFIRM THE PRESENCE OF DEGRADED SOUND ABATEMENT FOAM. VISUALLY, THE SOUND ABATEMENT FOAM LOOKED INTACT BUT HAD DUST-LIKE CONTAMINATION ON IT. PIL WAS NOT ABLE TO CONFIRM THE COMPLAINT OR ADDRESS THE SYMPTOMS SPECIFIED. PIL WAS NOT ABLE TO GET CARE ORCHESTRATOR INFORMATION FROM THE DEVICE. QUANTITY OF 1 ERROR# 15 (ERR_CYCLE_HANDLER_OVERRUN) LEVEL ¿ REBOOT RATIONALE - THE TEN MILLISECOND (10MS) CYCLE HANDLER DID NOT FINISH COMPLETING BEFORE ANOTHER CALL TO IT WAS MADE. ACCORDING TO THE SERVICE MANUAL 1128168 V10, IT IS RECOMMENDED, IF ERROR WAS NOT LAST STOP ERROR, TO CLEAR ERROR LOG AND TEST. SERVICE MANUAL 1128168 V10 AND ERROR CODE RATIONALE (B)(4) WAS V04 WAS REFERENCED. DEVICE WAS LIKELY RESET PRIOR TO PIL RECEIPT AS INDICATED BY THE DEVICE HAVING 4376.5 MACHINE HOURS AND NO BLOWER OR THERAPY HOURS. IN BOX D: DEVICE AVAILABLE FOR EVAL AND DATE RETURNED TO MFG HAS BEEN UPDATED. IN BOX H: DEVICE EVAL. BY MFG, (DEVICE) PROBLEM CODE GRID, EVALUATION METHOD CODE GRID, EVALUATION RESULTS CODE GRID, COMPONENT CODE GRID, CONCLUSION CODE GRID HAS BEEN UPDATED.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE REPORTER ALLEGED KIDNEY DISEASE/TOXICITY. MEDICAL INTERVENTION WAS NOT SPECIFIED. NO ADDITIONAL INFORMATION CAN BE REQUESTED AT THIS TIME. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299309 DREAMSTATION GO AUTO VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSG500S11

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other