BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION AUTO CPAP

    MDR report key: 13252042 · Received January 13, 2022

    Report

    Report Number
    2518422-2022-00894
    Event Type
    Malfunction
    Date Received
    January 13, 2022
    Date of Event
    December 16, 2021
    Report Date
    October 30, 2023
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K131982
    Removal / Correction Number
    RES 88058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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 PREVIOUSLY REPORTED AN ALLEGATION OF AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE MANUFACTURER RECEIVED INFORMATION ALLEGED CDL MACHINE MALFUNCTION, ODOR, BURN MARK ON BED SIDE TABLE, NOISY MACHINE, LIGHTHEADED AND DIZZY, HEADACHES, SINUS INFLAMMATION, RASH ON FOREARMS, NASAL/THROAT IRRITATION OR SORENESS AND PARTICLES IN TUBING/CHAMBER. THERE WAS NO REPORT OF SERIOUS OR PERMANENT HARM OR INJURY. SECTION B5 WAS INCORRECTLY REPORTED IN THE PREVIOUS REPORT. IT HAS TO BE REPORTED AS: THE MANUFACTURER RECEIVED INFORMATION ALLEGEING CDL MACHINE MALFUNCTION, ODOR, BURN MARK ON BED SIDE TABLE, NOISY MACHINE, LIGHTHEADED AND DIZZY, HEADACHES, SINUS INFLAMMATION, RASH ON FOREARMS, NASAL/THROAT IRRITATION OR SORENESS AND PARTICLES IN TUBING/CHAMBER RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY FOR FURTHER INVESTIGATION. THE INTERNAL AND EXTERNAL PARTS OF THE DEVICE WERE EVALUATED. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE MANUFACTURER. THERE WERE 2 ERRORS FOUND. THERE WAS UNKNOWN DUST CONTAMINATION OBSERVED ON THE TOP ENCLOSURE, FRONT PANEL, REAR PANEL, BOTTOM ENCLOSURE, BLOWER, BLOWER SEAL, AND BLOWER BOX. EVIDENCE OF LIQUID INGRESS WAS OBSERVED TO THE BLOWER AND BLOWER BOX. A KERATIN-LIKE SUBSTANCE WAS OBSERVED ON THE BLOWER BOX OUTLET. THE MANUFACTURER CONCLUDES THAT THEY COULD NOT DIRECTLY CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS NO VISIBLE FOAM DEGRADATION, BUT DUST CONTAMINATION WAS OBSERVED.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915247 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX500T11C

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown