BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMSTAR AUTO

    MDR report key: 20375868 · Received October 4, 2024

    Report

    Report Number
    2518422-2024-60646
    Event Type
    Injury
    Date Received
    October 4, 2024
    Date of Event
    October 9, 2023
    Report Date
    May 2, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959005907
    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

    REPAIR EVALUATION INFORMATION WAS RECEIVED ON 02/05/2025 AND SECTION H11 SHOULD BE REPORTED AS: 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 CANCER. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S QUALITY PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION. THE MANUFACTURE INSPECTED EXTERNALLY OBSERVED THAT USING A KNOWN GOOD POWER SUPPLY AND POWER CORD, PIL TECH WAS ABLE TO CONFIRM THE DEVICE POWERS ON AND PROVIDED AIRFLOW. DURING REVIEW OF THE ERROR LOGS, PIL DETERMINED THAT THE DEVICE HAD 13518.7 MACHINE HOURS, 13518.7 BLOWER HOURS AND 13434.0 THERAPY HOURS. THE ERROR LOG SHOWED 18 ERRORS LOGGED. 18 INSTANCES OF E-53 (ERR_COMP_LOG_SEM_TIMEOUT) A CONTINUE ERROR. C"A COMPLIANCE LOG/ERROR LOG/EVENT LOG MUTEX SEMAPHORE HAS BEEN HELD BY A CLIENT FOR 2/1/2 SECONDS RESPECTIVELY, WITHOUT RELEASING IT. THE RASP CLIENT IS EXEMPT FROM GENERATING THIS ERROR, SINCE THE MODEM MAY RESET OR BE REMOVED DURING LOGGING. IN THIS CASE, THE SEMAPHORE IS SIMPLY RELEASED. ORCHESTRATOR DATA WAS NOT AVAILABLE FOR DOWNLOAD. DURING THE INVESTIGATION PIL OBSERVED DAMAGE TO THE LEFT AND RIGHT SIDE OF THE TOP COVER. SEVERAL SCRATCHES WERE OBSERVED ON THE LEFT SIDE PANEL. DUST-LIKE CONTAMINATION WAS OBSERVED ON THE RIGHT SIDE PANEL, IN THE ISO PORT, AIR INLET, ON THE INTERIOR SIDE OF THE TOP COVER, AROUND THE CONTROL KNOB OF THE PCA, ON THE INTERIOR SIDE OF THE LEFT PANEL, ON AND UNDER THE BLOWER CAP, ON AND IN THE BLOWER MOTOR, IN THE BASE OF AND UNDER THE BLOWER HOUSING, ON THE SOUND ABATEMENT FOAM AND WALLS OF THE BOTTOM ENCLOSURE. EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION/BREAKDOWN WAS NOT OBSERVED. THE MANUFACTURER CONCLUDES THERE WAS NO EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION AND THERE IS NO VISIBLE DAMAGE OR FUNCTIONALITY FAILURES OF THE DEVICE. THE MANUFACTURER OBSERVED DUST CONTAMINATION AND WATER MARKS IN THE DEVICE AND ARE CONSISTENT WITH BEING FROM AN EXTERNAL SOURCE. IN BOX H-DEVICE PROBLEM CODE GRID, EVALUATION METHOD CODE, EVALUATION RESULTS CODE, COMPONENT CODE GRID AND CONCLUSION CODE GRID HAS BEEN UPDATED. IN BOX D: DEVICE AVAILABLE FOR EVAL AND DATE RETURNED TO MFG 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 MANUFACTURER RECEIVED INFORMATION ALLEGING CANCER. NO MEDICAL INTERVENTION WAS SPECIFIED BY THE PATIENT. 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
    1443360 REMSTAR AUTO VENTILATOR, NON-CONTINUOUS (RESPIRATOR BZD RESPIRONICS, INC. DS560TS 00606959005907

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other