BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 6948486 · Received October 13, 2017

    Report

    Report Number
    8020893-2017-07744
    Event Type
    Malfunction
    Date Received
    October 13, 2017
    Report Date
    February 15, 2018
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: AN INSPIRATORY AUTOZERO SOLENOID WAS RETURNED TO COVIDIEN/ MEDTRONIC¿S PRODUCT ANALYSIS. A VISUAL INSPECTION OF THE RETURNED COMPONENT WAS PERFORMED, NO NOTABLE CONDITIONS WERE FOUND. THE RETURNED COMPONENT WAS INSTALLED INTO A TEST VENTILATOR FOR ANALYSIS AND FUNCTIONALITY TESTING WAS PERFORMED, NO ERRORS WERE RECORDED IN THE DIAGNOSTIC LOGS. AN INVESTIGATION WAS PERFORMED AND THE PRODUCT ANALYSIS TECHNICIAN REPORTED THAT NO FAULT WAS FOUND. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    COVIDIEN/MEDTRONIC HAS NOT RECEIVED THE DEVICE/COMPONENT FROM THE CUSTOMER FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE IN USE, THE 840 VENTILATOR BECAME INOPERABLE. THE PATIENT WAS REPORTEDLY TO HAVE BEEN AMBU BAGGED AND TRANSFERRED TO AN ALTERNATE VENTILATOR. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728016 840 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1