BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K181166

    MDR report key: 15901147 · Received December 2, 2022

    Report

    Report Number
    2518422-2022-100757
    Event Type
    Malfunction
    Date Received
    December 2, 2022
    Date of Event
    September 7, 2022
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    UDI-DI
    00606959051942
    PMA / PMN Number
    K181166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WAS ALARMING FOR SERVICE REQUIRED. THERE WAS NO HARM OR INJURY REPORTED. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. THE DEVICE'S SYSTEM BOARD NEEDS TO REPLACED TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2464165 K181166 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. DS2110X11B 00606959051942

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown