BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS CPAP DEVICE

    MDR report key: 19002333 · Received March 29, 2024

    Report

    Report Number
    2518422-2024-15033
    Event Type
    Injury
    Date Received
    March 29, 2024
    Date of Event
    March 1, 2022
    Report Date
    July 25, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    Removal / Correction Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 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 PREVIOUSLY RECEIVED INFORMATION ALLEGING SEVERE DRY MOUTH THAT WAS SEEN BY PRIMARY CARE AND ENT DOCTOR, INFLAMED THROAT AND TONSIL INFECTION. MEDICAL INTERVENTION WAS NOT SPECIFIED. THERE IS NO CUSTOMER INFORMATION HENCE WE CANNOT REACH OUT TO THE CUSTOMER 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 WAS UPDATED IN THIS REPORT.

    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.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED A VOLUNTARY MEDWATCH (MW-5151986) IN WHICH THE PATIENT ALLEGES SEVERE DRY MOUTH THAT WAS SEEN BY PRIMARY CARE AND ENT DOCTOR, INFLAMED THROAT AND TONSIL INFECTION. 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
    2592759 PHILIPS CPAP DEVICE VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention