BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 4221654 · Received November 3, 2014

    Report

    Report Number
    8020893-2014-02438
    Event Type
    Injury
    Date Received
    November 3, 2014
    Report Date
    October 9, 2014
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) EVALUATED THE DEVICE AND VERIFIED THE REPORTED ISSUE. THE CSE REPLACED THE AUTOZERO SOLENOID, WHICH RESOLVED THE REPORTED ISSUE. THE VENTILATOR PASSED EXTENDED SELF TESTS (EST), SHORT SELF TESTS (SST), AND ELECTRICAL SAFETY TEST. (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION THAT, DURING PATIENT USE, AN 840 VENTILATOR EXPERIENCED A MALFUNCTION. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE DEVICE. THERE WAS NO HARM OR INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702869 840 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention