BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS CPAP DEVICE

    MDR report key: 19059117 · Received April 8, 2024

    Report

    Report Number
    2518422-2024-15110
    Event Type
    Malfunction
    Date Received
    April 8, 2024
    Date of Event
    February 16, 2024
    Report Date
    August 13, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    Removal / Correction Number
    UKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. H3 OTHER TEXT : DEVICE NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER RECEIVED A VOLUNTARY MEDWATCH (MW 5152032) IN WHICH THE PATIENT ALLEGES THAT HAVE EXPERIENCE CONTINUOUS ALLERGY LIKE SYMPTOMS SUCH AS SNEEZING, NASAL CONGESTION ETC. MEDICAL INTERVENTION WAS NOT SPECIFIED. REPEATED ATTEMPTS TO HAVE THE DEVICE AND COMPONENTS RETURNED FOR EVALUATION AND INVESTIGATION WERE UNSUCCESSFUL. THE MANUFACTURER BELIEVES THEY WILL BE UNABLE TO GATHER ADDITIONAL INFORMATION. THE MANUFACTURER IS SUBMITTING A FINAL REPORT AT THIS TIME. IF PERTINENT INFORMATION BECOMES AVAILABLE TO THE MANUFACTURER AT A LATER DATE, AN ADDENDUM TO THIS FINAL REPORT WILL BE FILED. BOX H: COMPONENT CODE GRID HAS BEEN UPDATED.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED A VOLUNTARY MEDWATCH (MW 5152032) IN WHICH THE PATIENT ALLEGES THAT HAVE EXPERIENCE CONTINOUS ALLERGY LIKE SYMPTOMS SUCH AS SNEEZING, NASAL CONGESTION ETC. MEDICAL INTERVENTION WAS NOT SPECIFIED. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR INVESTIGATION. 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
    417518 PHILIPS CPAP DEVICE VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown