BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION CPAP PRO

    MDR report key: 16753772 · Received April 17, 2023

    Report

    Report Number
    2518422-2023-09079
    Event Type
    Malfunction
    Date Received
    April 17, 2023
    Date of Event
    April 4, 2023
    Report Date
    June 5, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K131982
    Removal / Correction Number
    RES 88058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER WAS PREVIOUSLY 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 AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGED TO EXPERIENCING NASAL/THROAT IRRITATION /SORENESS AND CHEST PAIN. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. THERE WAS NO MEDICAL INTERVENTION REQUIRED BY THE PATIENT. THE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER. THE TECHNICIAN CONFIRMED NO EVIDENCE OF FOAM PARTICLES IN THE AIR PATH DURING THE DEVICE EVALUATION. THERE WERE SOME SECONDARY FINDINGS.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS PREVIOUSLY 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 AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGED TO EXPERIENCING NASAL/THROAT IRRITATION /SORENESS AND CHEST PAIN. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. THERE WAS NO MEDICAL INTERVENTION REQUIRED BY THE PATIENT. THE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER. THE TECHNICIAN CONFIRMED NO EVIDENCE OF FOAM PARTICLES IN THE AIR PATH DURING THE DEVICE EVALUATION. THERE WERE SOME SECONDARY FINDINGS.

    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, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGED TO EXPERIENCING NASAL/THROAT IRRITATION /SORENESS AND CHEST PAIN. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. THERE WAS NO MEDICAL INTERVENTION REQUIRED BY THE PATIENT. 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
    1808115 DREAMSTATION CPAP PRO VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. CAX400T12

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown