BEUDAMED
    FDA Adverse Event Injury Summary report: N

    980 VENTILATOR

    MDR report key: 4100304 · Received September 18, 2014

    Report

    Report Number
    8020893-2014-02223
    Event Type
    Injury
    Date Received
    September 18, 2014
    Date of Event
    August 18, 2014
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K131252
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND FOUND AN ERROR MESSAGE RELEVANT TO THE ALLEGED MALFUNCTION RECORDED IN THE ERROR LOGS. THE CSE WAS NOT ABLE TO DUPLICATE THE MALFUNCTION. THE CSE PERFORMED EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED. (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION STATING THAT WHILE IN USE ON A PATIENT A 980 VENTILATOR GENERATED AN ERROR MESSAGE THAT RENDERED IT INTO AN INOPERABLE STATE. THE PATIENT'S CONDITION WAS REPORTED TO BE STABLE STATE. THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND FOUND AN ERROR MESSAGE RELEVANT TO THE ALLEGED MALFUNCTION RECORDED IN THE ERROR LOGS. THE CSE WAS NOT ABLE TO DUPLICATE THE MALFUNCTION. THE CSE PERFORMED EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580403 980 VENTILATOR VENTILATOR, CONTINUOUS USE, FACILITY USE CBK COVIDIEN 980

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention