BEUDAMED
    FDA Adverse Event Injury Summary report: N

    980 VENTILATOR

    MDR report key: 4806600 · Received May 29, 2015

    Report

    Report Number
    8020893-2015-00495
    Event Type
    Injury
    Date Received
    May 29, 2015
    Report Date
    April 29, 2015
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K131252
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REMOVED FROM THE VENTILATOR ALLEGATING THE VENTILATOR MISSED TO DELIVER BREATHS DURING NON INVASIVE VENTILATION. THERE WAS NO REPORT OF SERIOUS INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348462 980 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN 980

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention