BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION AUTO CPAP

    MDR report key: 15329919 · Received August 31, 2022

    Report

    Report Number
    2518422-2022-76621
    Event Type
    Malfunction
    Date Received
    August 31, 2022
    Date of Event
    September 14, 2021
    Report Date
    July 25, 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 HAVING HEADACHES, FEELING STUFFY, AND A SORE THROAT. THERE WAS NO REPORT OF SERIUOS OR PERMANENT 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 DUST/DIRT CONTAMINATION INCONSISTENT WITH DEGRADED SOUND ABATEMENT FOAM WAS OBSERVED THROUGHOUT DEVICE ENCLOSURE, AND AIRPATH, SUGGESTING A SOURCE EXTERNAL TO THE DEVICE. SLIGHT BLACK CONTAMINATION AT THE BLOWER SEAL OF THE BLOWER BOX IS CONSISTENT WITH THE KERATIN CONTAMINATION OBSERVED IN ER 2243857 V1. THE MANUFACTURER FOUND NO EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION/BREAKDOWN. THE DEVICE'S EVENT LOGS WERE DOWNLOADED AND REVIEWED. NO ERRORS WERE LOGGED. THE MANUFACTURER CONCLUDES THERE WAS NO EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION/BREAKDOWN WAS OBSERVED IN THIS DEVICE. SECTION D9, G3 AND H6 HAS BEEN UPDATED IN THIS REPORT.

    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, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING HEADACHES, STUFFY, SORE THROAT. THERE WAS NO REPORT OF SERIUOS OR PERMANENT 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
    2068632 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX500T11C

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown