BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION CPAP PRO

    MDR report key: 14787824 · Received June 23, 2022

    Report

    Report Number
    2518422-2022-43455
    Event Type
    Malfunction
    Date Received
    June 23, 2022
    Date of Event
    August 18, 2021
    Report Date
    November 29, 2024
    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
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 22 NOV, 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 AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT ALLEGED OF HAVING UPPER RESPIRATORY INFECTIONS WHICH HAS TRAVELED DOWN TO HER KNEE AND IS CURRENTLY ON MEDICATION. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. SECTION B1 WAS CORRECTED FOR PRODUCT PROBLEM. (BOTH ADVERSE EVENT AND PRODUCT PROBLEM WAS CHECKED IN THE PREVIOUS MDR.) SECTION B2 WAS CORRECTED TO BLANK. (PREVIOUSLY, IT WAS OTHER SERIOUS OR IMPORTANT MEDICAL EVENTS.) SECTION H1 WAS CHANGED FROM SERIOUS INJURY TO MALFUNCTION. SECTION H6 HEALTH EFFECTS: CLINICAL CODES AND HEALTH EFFECTS - IMPACT CODE WAS CORRECTED.

    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 OF HAVING UPPER RESPIRATORY INFECTIONS WHICH HAS TRAVELED DOWN TO HER KNEE AND IS CURRENTLY ON MEDICATION. 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
    1239807 DREAMSTATION CPAP PRO VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX400H11

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention