BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 5915980 · Received August 30, 2016

    Report

    Report Number
    8020893-2016-02231
    Event Type
    Injury
    Date Received
    August 30, 2016
    Report Date
    August 3, 2016
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COVIDIEN TECHNICAL SUPPORT ENGINEER (TSE) TROUBLESHOT THIS ISSUE WITH THE CUSTOMER OVER THE PHONE. TSE RECOMMENDED REPLACING THE BREATH DELIVERY (BD) PRINTED CIRCUIT BOARD (PCB). THE CUSTOMER REPORTED TO HAVE REPLACED THE BD PCB.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT AN 840 VENTILATOR GENERATED AN INOPERABLE DIAGNOSTIC MESSAGE. THE PATIENT WAS REMOVED FORM THE VENTILATOR AND MANUALLY VENTILATED VIA AN AMBU BAG. THE PATIENT WAS 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
    566379 840 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention