BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOSPIRE DELUXE

    MDR report key: 21457184 · Received February 25, 2025

    Report

    Report Number
    2518422-2025-021946
    Event Type
    Malfunction
    Date Received
    February 25, 2025
    Date of Event
    July 24, 2023
    Report Date
    July 9, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K131982
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED "THE MANUFACTURER RECEIVED INFORMATION ALLEGING A ELECTRICAL BURNOUT AND BROKEN ON OFF SWITCH." UPON FURTHER REVIEW, IT WAS IDENTIFIED THAT DEVICE INVOLVED IN THE COMPLAINT WAS NOT MANUFACTURED BY PHILIPS, INC. THE COMPLIANT WAS INITIALLY INCORRECTLY REPORTED AS A PHILIPS CPAP DEVICE IN MDR 2518422-2025-021946. THE DEVICE IDENTIFIED IN THE COMPLAINT IS A INNOSPIRE DELUXE (SN (B)(6) / REF (B)(4)/ LOT NO 1903-CN3WL). THE COMPLAINT INFORMATION HAS BEEN FORWARDED TO THE DEVICE MANUFACTURER.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A ELECTRICAL BURNOUT AND BROKEN ON OFF SWITCH. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464012 INNOSPIRE DELUXE VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. 1112279

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown