BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAMSTATION AUTO CPAP

    MDR report key: 15117429 · Received July 27, 2022

    Report

    Report Number
    2518422-2022-64115
    Event Type
    Injury
    Date Received
    July 27, 2022
    Date of Event
    August 30, 2021
    Report Date
    September 13, 2023
    Manufacturer
    RESPIRONICS, 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
    TN, 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 RECEIVED INFORMATION ALLEGING VISUALIZATION OF PARTICLES RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER FOR FURTHER EVALUATION. THE DEVICE WAS EVALUATED. 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. 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). THERE WERE NO ERRORS FOUND. THE MANUFACTURER CONCLUDES THAT THEY COULD NOT CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS VISIBLE FOAM DEGRADATION.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT ALLEGED HAVING 3 SKIN CANCERS REMOVED FROM FACE, TWO SUSPICIOUS SPOTS THAT APPEAR TO BE THE SAME THING. THE PATIENT ALSO DEVELOPED KIDNEY AND LIVER PROBLEMS. 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
    2655550 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX500H11C

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other