BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 4252086 · Received November 14, 2014

    Report

    Report Number
    8020893-2014-02473
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 27, 2014
    Report Date
    October 27, 2014
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A COVIDIEN TECHNICAL SUPPORT ENGINEER (TSE) TROUBLESHOT THIS ISSUE WITH THE CUSTOMER OVER THE PHONE. THE TSE RECOMMENDED REPLACING GRAPHICAL USER INTERFACE (GUI) TOUCH FRAME PRINTED CIRCUIT BOARD (PCB). DURING A FOLLOW-UP WITH THE USER FACILITY, THE DEVICE WAS FOUND TO HAVE BEEN REPAIRED BY THE USER. THE USER FACILITY REPORTED TO HAVE REPLACED THE TOUCH FRAME TO RESOLVE THE ISSUE. THE DEVICE WAS RETURNED TO CLINICAL USE WITHOUT INCIDENT. (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION STATING THAT AN 840 VENTILATOR EXPERIENCED A TOUCH SCREEN BLOCKED WHILE IN USE ON A PATIENT. 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
    737684 840 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention