BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION AUTO CPAP

    MDR report key: 12751192 · Received November 4, 2021

    Report

    Report Number
    2518422-2021-06281
    Event Type
    Malfunction
    Date Received
    November 4, 2021
    Date of Event
    August 24, 2021
    Report Date
    June 26, 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 BLACK PARTICLES IN WATER. THERE WAS NO REPORT OF SERIOUS OR PERMANENT HARM OR INJURY. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY FOR FURTHER INVESTIGATION. THE MANUFACTURER FOUND EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION/BREAKDOWN WAS NOT OBSERVED IN THE BASE UNIT. 0 BLOWER HOURS AND 0 THERAPY HOURS WERE LOGGED, SUGGESTING THE DEVICE DATA WAS RESET PRIOR TO PIL RECEIPT. 7130.2 MACHINE HOURS WERE LOGGED.THE DUST/DIRT CONTAMINATION FOUND ON THE BOTTOM CASING, ON THE BLOWER BOX, AND ON THE MOTOR CASING/IMPELLERS WAS INCONSISTENT WITH DEGRADED SOUND ABATEMENT FOAM CONTAMINATION. THE PRESENCE OF CONTAMINATION THROUGHOUT THE AIRPATH, SUGGESTS A SOURCE EXTERNAL TO THE DEVICE. MINERAL DEPOSITS WERE FOUND ON THE INSIDE OF THE BLOWER BOX SUGGESTING WATER INGRESS. SLIGHT BLACK CONTAMINATION WAS FOUND AT THE BLOWER SEAL OF THE BLOWER BOX, AND IT IS CONSISTENT WITH THE KERATIN CONTAMINATION OBSERVED IN ER 2243857. PIL IS UNABLE TO CONFIRM THE COMPLAINTS OF BLACK PARTICLES IN WATER. PIL CAN CONFIRM THE PRESENCE OF CONTAMINATION IN THE AIRPATH. PIL CAN CONFIRM THAT THERE IS EVIDENCE OF WATER INGRESS INTO THE BLOWER BOX ASSEMBLY. THE MANUFACTURER CONCLUDES THE CONTAMINATION FOUND WAS CONSISTENT WITH KERATIN. THERE WAS NO EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION FOUND WITHIN THE DEVICE.

    Description of Event or Problem · 1

    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
    1652375 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX500T11C

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown