BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS DREAM STATION CPAP

    MDR report key: 15286857 · Received August 24, 2022

    Report

    Report Number
    2518422-2022-73780
    Event Type
    Malfunction
    Date Received
    August 24, 2022
    Date of Event
    July 28, 2022
    Report Date
    August 16, 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
    003

    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, HEADACHES, SHORTNESS OF BREATH AND CONGESTION RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF SERIOUS OR PERMANENT PATIENT HARM OR INJURY. SINCE THERE IS NO CUSTOMER INFORMATION, THE MANUFACTURER BELIEVES THEY WILL BE UNABLE TO GATHER ADDITIONAL INFORMATION. THE MANUFACTURER IS SUBMITTING AN UPDATED REPORT AT THIS TIME. IF PERTINENT INFORMATION BECOMES AVAILABLE TO THE MANUFACTURER AT A LATER DATE, FOLLOW-UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED AN ALLEGATION OF AN ISSUE RELATED TO SOUND ABATEMENT FOAM. UPON FURTHER REVIEW, THIS DEVICE WAS A REPAIRED DEVICE AND DID NOT CONTAIN SOUND ABATEMENT FOAM THAT WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY AND IS NOT IN SCOPE OF RES (B)(4). THEREFORE, THERE IS NO ALLEGATION OF A REPORTABLE EVENT ASSOCIATED WITH THE DEVICE AT THIS TIME.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS CONTACTED BY VOLUNTARY MEDWATCH (MW 5110920) 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 RECEIVED INFORMATION ALLEGING THE PATIENT VISUALIZED BLACK PARTICLES. THE PATIENT ALLEGES TO HAVE HEADACHES, SHORTNESS OF BREATH AND CONGESTION. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. 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
    2236283 PHILIPS DREAM STATION CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. 999998

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown