BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 3830638 · Received May 5, 2014

    Report

    Report Number
    8020893-2014-01060
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    January 29, 2014
    Report Date
    February 3, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND WAS NOT ABLE TO REPRODUCE THE ALLEGED MALFUNCTION. THE CSE PERFORMED EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED. (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM (B)(6) WITH INFORMATION STATING THAT A PATIENT DID NOT FEEL AIR BLOW WHILE CONNECTED TO AN 840 VENTILATOR. THE VENTILATOR WAS REPORTED TO HAVE BEEN IN SPONTANEOUS MODE VENTILATION. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR. THE PATIENT WAS NOT HARMED ON INJURED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267333 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention