BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 4121822 · Received September 26, 2014

    Report

    Report Number
    8020893-2014-02182
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 2014
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND COULD NOT DUPLICATE THE MALFUNCTION. THE DEVICE PASSED ALL TESTING AND OPERATED ACCORDING TO MANUFACTURING SPECIFICATIONS. NO PARTS WERE REPLACED. (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION THAT THE 840 VENTILATOR KEEP ALARMING AFTER A POWER FAILURE DURING PATIENT USE. THE VENTILATOR CONTINUED TO VENTILATE THE PATIENT BUT WAS SWAPPED DUE TO CONTINUOUS ALARM. THERE WAS NO PATIENT HARM OR INJURY AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602102 840 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention