BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION CPAP PRO

    MDR report key: 12046333 · Received June 22, 2021

    Report

    Report Number
    2518422-2021-01827
    Event Type
    Malfunction
    Date Received
    June 22, 2021
    Date of Event
    June 21, 2021
    Report Date
    October 3, 2022
    Manufacturer
    PHILIPS RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959027251
    PMA / PMN Number
    K131982
    Removal / Correction Number
    RES 88058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED AN ALLEGATION RELATED TO SOUND ABATEMENT FOAM. THIS ACTION WAS REPORTED TO FDA PER 21 CFR PART 806. THE DEVICE WILL BE CORRECTED PER RES 88058.

    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 RECEIVED INFORMATION ALLEGING THE PATIENT OBSERVED BLACK PARTICLES INSIDE THE MASK AND THE FILTERS. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. DESPITE OF THREE ATTEMPTS (B)(6) 2022, (B)(6) 2022, (B)(6) 2022 ; THE DEVICE HAS NOT YET RETURNED TO THE MANUFACTURER FOR EVALUATION. THERE HAS BEEN NO RESPONSE FROM THE CUSTOMER ON THE RETURN OF THE DEVICE. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. 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
    941582 DREAMSTATION CPAP PRO VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILIPS RESPIRONICS, INC. ITX400S15 00606959027251

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown