BEUDAMED
    FDA Adverse Event Injury Summary report: N

    980 VENTILATOR

    MDR report key: 4153012 · Received October 8, 2014

    Report

    Report Number
    8020893-2014-02316
    Event Type
    Injury
    Date Received
    October 8, 2014
    Report Date
    September 9, 2014
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K131252
    Removal / Correction Number
    RES69324
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN CUSTOMER SUPPORT ENGINEER INSPECTED THE DEVICE AND IDENTIFIED THAT THE BACKLIGHT INVERTER BOARD TO BE DEFECTIVE. THE DEVICE WAS REPLACED AND RETURNED TO COVIDIEN. (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION STATING THAT DURING PATIENT USE, THE 980 VENTILATOR CAUSED A VISIBLE HAZE. THE PATIENT WAS PLACED ON ANOTHER VENTILATOR. THERE WAS NO PATIENT HARMED OR INJURED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631991 980 VENTILATOR VENTILATOR, CONTINUOUS USE, FACILITY USE CBK COVIDIEN 980

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention