BEUDAMED
    FDA Adverse Event Injury Summary report: N

    980 VENTILATOR

    MDR report key: 4813071 · Received June 2, 2015

    Report

    Report Number
    8020893-2015-00501
    Event Type
    Injury
    Date Received
    June 2, 2015
    Report Date
    February 16, 2015
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K131252
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION STATING THAT DURING USE ON A PATIENT, THE PROXIMAL (PROX) FLOW MEASUREMENTS WERE LOWER THAN THE SET TIDAL VOLUME (VT) THAN THOSE SET ON THE 980 VENTILATOR. IT WAS REPORTED THAT THE PATIENT'S CARBON DIOXIDE (CO2) LEVEL AND WORK OF BREATHING (WOB) INCREASED AND THE CHEST X-AY SHOWED 'WHITE OUT". THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR. INFORMATION REGARDING THE PATIENT OUTCOME WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354583 980 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN 980

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention