BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 6169101 · Received December 13, 2016

    Report

    Report Number
    8020893-2016-03410
    Event Type
    Injury
    Date Received
    December 13, 2016
    Date of Event
    November 14, 2016
    Report Date
    November 14, 2016
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ALLEGED MALFUNCTION WAS NOT DUPLICATED. THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER STATES: DURING USE, THE SUCTION PORT OF THE CATHETER MOUNT WAS OPEN AND THE VENTILATION HAD NOT STARTED. LATER, THE PATIENT PASSED AWAY. THE HOSPITAL SIDE DOESN'T THINK THE DEATH IS RELATED TO THE DEVICE FAULT BECAUSE THE PATIENT WAS HOSPITALIZED IN CARDIOPULMONARY ARREST STATE. THE CIRCUIT WAS A FISHER AND PIKEL, THE CATHETER MOUNT WAS A SMITH MEDICAL. IT WAS CONFIRMED THAT THE VENTILATION DOESN'T START WHEN THE SUCTION CAP IS OPEN. IT STARTED WHEN THE CAP WAS CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822527 840 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R