BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 3851111 · Received May 22, 2014

    Report

    Report Number
    8020893-2014-01222
    Event Type
    Injury
    Date Received
    May 22, 2014
    Report Date
    April 22, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    A COVIDIEN TECHNICAL SUPPORT ENGINEER (TSE) TROUBLESHOT THIS ISSUE WITH THE CUSTOMER OVER THE PHONE. THE CUSTOMER STATES THAT HE PERFORMED CALIBRATIONS AND THE EXTENDED SELF-TEST (EST) AND RAN THE VENTILATOR ON A TEST LUNG. THE CUSTOMER THEN REPORTED REPLACING THE PROPORTIONAL SOLENOID (PSOL) AND RAN THE PERFORMANCE VERIFICATION TEST (PVT). ALL TESTS PASSED. COVIDIEN WAS NOT AUTHORIZED TO EVALUATE THE DEVICE. (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FORM THE USA STATING THAT AN 840 VENTILATOR EXPERIENCED A MALFUNCTION DURING PATIENT USE. THE CUSTOMER REPORTED THAT WHILE VENTILATING AN INOPERATIVE ALARM WAS DISPLAYED. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306660 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention