BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAMSTATION BIPAP AVAPS30

    MDR report key: 14315881 · Received May 7, 2022

    Report

    Report Number
    2518422-2022-17991
    Event Type
    Injury
    Date Received
    May 7, 2022
    Date of Event
    April 14, 2022
    Report Date
    May 23, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNS
    UDI-DI
    00606959045651
    PMA / PMN Number
    K102465
    Removal / Correction Number
    RES 88058
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED RECEIVED AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM ALLEGING BREAST CANCER, NOSE BLEEDS, AND HEADACHES WHILE USING THE DEVICE. MEDICAL INTERVENTION WAS NOT SPECIFIED. DESPITE OF THREE ATTEMPTS 08/01/2022, 08/04/2022, 08/08/2022 ; THE DEVICE HAS NOT YET RETURNED TO THE MANUFACTURER FOR EVALUATION. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON MAY 28, 2024 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 PREVIOUSLY RECEIVED INFORMATION ALLEGING ALLEGING BREAST CANCER, NOSE BLEEDS, AND HEADACHES THAT ARE RELATED CPAP DEVICE'S SOUND ABATEMENT FOAM. MEDICAL INTERVENTION WAS NOT SPECIFIED. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION. DURING THE INVESTIGATION MANUFACTURER OBSERVED AN UNKNOWN BROWN CONTAMINATE ON THE TOP ENCLOSURE. AN UNKNOWN DUST-LIKE CONTAMINATE ON THE FRONT PANEL, TOP ENCLOSURE, REAR PANEL, BOTTOM ENCLOSURE. A HEAVY DUST-LIKE MATERIAL NEXT TO THE AIR INLET. A DEEP SCRATCH ACROSS THE WARNING LABEL ON THE BOTTOM ENCLOSURE. A POWDERED DUST LIKE MATERIAL ON TOP OF THE UI PANEL. A LIGHT DUST LIKE MATERIAL ON THE BLOWER. DRIED LIQUID SPOTS WITH MINERAL DEPOSITS ON THE BOTTOM OF THE BLOWER, BLOWER BOX. A POSSIBLE KERATIN-LIKE SUBSTANCE IS OBSERVED AROUND THE BLOWER BOX OUTLET. EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION/BREAKDOWN WAS NOT OBSERVED. THE MANUFACTURER USED A FITT (FOAM INTEGRITY TEST TOOL) AND WAS NOT ABLE TO CONFIRM THE PRESENCE OF DEGRADED SOUND ABATEMENT FOAM. THE DEVICE'S EVENT LOGS WERE DOWNLOADED AND REVIEWED BY MANUFACTURER. THE MANUFACTURER FOUND ONE ERROR CODES. THE MANUFACTURER APPLIED POWER TO THE DEVICE AND VERIFIED AIRFLOW. THE MANUFACTURER CONCLUDES, THERE WAS NO EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION/BREAKDOWN AND OBSERVED DUST LIKE CONTAMINATION AND WAS NOT ABLE TO CONFIRM THE COMPLAINT OR ADDRESS THE SYMPTOMS SPECIFIED. SECTIONS D8, D9, H2, H3 AND H6 HAS BEEN UPDATED IN THIS REPORT.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT ALLEGED BREAST CANCER, NOSE BLEEDS, AND HEADACHES WHILE USING THE DEVICE. MEDICAL INTERVENTION WAS NOT SPECIFIED. 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
    1204930 DREAMSTATION BIPAP AVAPS30 VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS, INC. DSX1130H11C 00606959045651

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other