BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION AUTO CPAP

    MDR report key: 15131733 · Received July 29, 2022

    Report

    Report Number
    2518422-2022-65612
    Event Type
    Malfunction
    Date Received
    July 29, 2022
    Date of Event
    October 1, 2021
    Report Date
    July 20, 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 PREVIOUSLY RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. PATIENT ALLEGED SINUS INFECTION. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION. AN EXTERNAL AND INTERNAL VISUAL INSPECTION OF THE DEVICE WAS COMPLETED BY THE MANUFACTURER. THE MANUFACTURER FOUND EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION/BREAKDOWN WAS NOT OBSERVED IN THE BASE UNIT, SLIGHT BLACK CONTAMINATION AT THE BLOWER SEAL OF THE BLOWER BOX IS CONSISTENT WITH THE KERATIN CONTAMINATION OBSERVED IN ER 2243857 (V1). DUST/DIRT CONTAMINATION INCONSISTENT WITH DEGRADED SOUND ABATEMENT FOAM WAS OBSERVED THROUGHOUT DEVICE ENCLOSURE, AND AIRPATH, SUGGESTING A SOURCE EXTERNAL TO THE DEVICE. THE DEVICE'S EVENT LOGS WERE DOWNLOADED AND REVIEWED. NO ERRORS WERE LOGGED. THE MANUFACTURER CONCLUDES BLACK CONTAMINATION AT THE BLOWER SEAL OF THE BLOWER BOX, DUST/DIRT CONTAMINATION INCONSISTENT WITH DEGRADED SOUND ABATEMENT FOAM. THE MANUFACTURER CONFIRMED THE PRESENCE OF CONTAMINATION IN THE AIRPATH. SECTION D9, G3 AND H6 HAS BEEN UPDATED IN THIS REPORT.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING SINUS INFECTION RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. 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
    1483767 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DNX500H11C

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown