BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAMSTATION AUTO CPAP

    MDR report key: 14304778 · Received May 6, 2022

    Report

    Report Number
    2518422-2022-17378
    Event Type
    Injury
    Date Received
    May 6, 2022
    Date of Event
    April 28, 2022
    Report Date
    August 26, 2024
    Manufacturer
    RESPORINOC INC
    Product Code
    BZD
    PMA / PMN Number
    K131982
    Removal / Correction Number
    RES 88058
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON APR 08, 2024, AND SECTION H11 SHOULD BE REPORTED AS: 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 RECEIVED INFORMATION ALLEGING A CPAP DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED CANCER. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION.MANUFACTURER CONFIRMED THE PRESENCE OF DEGRADED SOUND ABATEMENT FOAM USING A FITT AND THE ASSOCIATED PROCEDURE ER 2245460 (V.01). THE ISSUE OF DEGRADED SOUND ABATEMENT FOAM IS ADDRESSED BY CAPA 7211. MINERAL SPOTS CONSISTENT WITH WATER INGRESS WERE FOUND ON THE MOTOR CASING. A KERATIN-LIKE SUBSTANCE WAS OBSERVED AROUND THE BLOWER BOX OUTLET. THE OCCURRENCE OF A KERATIN-LIKE SUBSTANCE OBSERVED AROUND THE BLOWER BOX HAS BEEN PREVIOUSLY ADDRESSED IN ER 2243857 (V.01). THE DEVICE'S DOWNLOADED EVENT LOG WAS REVIEWED BY THE MANUFACTURER AND FOUND NO ERRORS. IN THIS REPORT, SECTIONS D9, G3, H3, AND H6 HAVE BEEN UPDATED OR CORRECTED.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A CPAP DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED CANCER. THE PATIENT DID NOT REPORT TO RECEIVE MEDICAL INTERVENTION. 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
    1215339 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPORINOC INC DSX500H11C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other