BEUDAMED
    FDA Adverse Event Injury Summary report: N

    980 VENTILATOR

    MDR report key: 6052322 · Received October 24, 2016

    Report

    Report Number
    8020893-2016-02828
    Event Type
    Injury
    Date Received
    October 24, 2016
    Date of Event
    October 18, 2016
    Report Date
    December 20, 2017
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K131252
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COVIDIEN SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND FOUND THE DEVICE FAILED POWER ON SELF-TEST (POST) AND UNABLE TO PASS EXTENDED SELF-TEST (EST). THE SE REPLACED THE INSPIRATORY FLOW MODULE PRINTED CIRCUIT BOARD (PCB). THE SE PERFORMED EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REPAIRED AND THE REPORTED ISSUE WAS ISOLATED TO INTERFACE BETWEEN THE DEVICE AND THE FAILED COMPONENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, THE MEASURED TIDAL VOLUME ON A 980 VENTILATOR WAS FLUCTUATING AND DID NOT LOOK TO BE CORRELATING WITH THE PATIENT CHEST RISE. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON 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
    702043 980 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN 980

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention