BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIP CPAP DEVICE

    MDR report key: 21500884 · Received March 2, 2025

    Report

    Report Number
    2518422-2025-024975
    Event Type
    Malfunction
    Date Received
    March 2, 2025
    Date of Event
    January 13, 2020
    Report Date
    July 25, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE NO DEVICE INFORMATION WAS PROVIDED, THE EXACT RECALL NUMBER IS UNKNOWN. POSSIBLE RECALL NUMBERS INCLUDE Z-1972-2021, Z-1973-2021, AND Z-1974-2021.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON OCTOBER 28, 2024, AND SECTION H11 SHOULD BE REPORTED AS: THE MANUFACTURER RECEIVED A VOLUNTARY MEDWATCH (MW5151051) IN WHICH THE PATIENT ALLEGES THAT HAVE BEEN DIAGNOSED WITH LUNG NODULES. MEDICAL INTERVENTION WAS NOT SPECIFIED. AFTER THE FIRST ATTEMPT TO HAVE THE DEVICE AND COMPONENTS EVALUATED, THE CUSTOMER HAS BEEN RESPONDED BUT DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER IS SUBMITTING AN UPDATED REPORT AT THIS TIME. AFTER DEVICE RETURN AND COMPLETION OF EVALUATION, A FOLLOW-UP REPORT WILL BE FILED. SECTION G AND H UPDATED IN THIS REPORT.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED A VOLUNTARY MEDWATCH (MW-5151051) IN WHICH THE PATIENT ALLEGES THAT HAVE BEEN DIAGNOSED WITH LUNG NODULES. MEDICAL INTERVENTION WAS NOT SPECIFIED. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THE MANUFACTURER'S INVETIGATION 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
    1147035 PHILIP CPAP DEVICE VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown