BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION AUTO CPAP

    MDR report key: 15209683 · Received August 11, 2022

    Report

    Report Number
    2518422-2022-69988
    Event Type
    Malfunction
    Date Received
    August 11, 2022
    Date of Event
    September 20, 2021
    Report Date
    August 11, 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 RECEIVED INFORMATION ALLEGING A CPAP DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED A PATIENT TO HAVE HEADACHES. THERE WAS NO REPORT OF SERIOUS OR PERMANENT PATIENT HARM OR INJURY. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S QUALITY PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION. THE MANUFACTURER VISUALLY INSPECTED THE INTERNAL AND EXTERNAL PARTS OF THE DEVICE AND FOUND DUST/DIRT CONTAMINATION INCONSISTENT WITH DEGRADED SOUND ABATEMENT FOAM WAS OBSERVED THROUGHOUT DEVICE ENCLOSURE, AND AIRPATH, SUGGESTING A SOURCE EXTERNAL TO THE DEVICE. EVIDENCE OF WATER INGRESS ON THE BLOWER AND BLOWER BOX. SLIGHT BLACK CONTAMINATION AT THE BLOWER SEAL OF THE BLOWER BOX IS CONSISTENT WITH THE KERATIN CONTAMINATION OBSERVED IN ER 2243857 V1. THE DEVICE'S EVENT LOGS WERE DOWNLOADED AND REVIEWED BY MANUFACTURER. THE MANUFACTURER FOUND NO ERROR CODES. THE MANUFACTURER CONCLUDES THERE WAS NO EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION/BREAKDOWN WAS OBSERVED IN THIS DEVICE.

    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. THERE WAS NO REPORT OF SERIOUS 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
    1786179 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX500H11C

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown