BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3982928 · Received July 2, 2014

    Report

    Report Number
    8020893-2014-01534
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    January 1, 2014
    Report Date
    June 3, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN TECHNICAL SUPPORT ENGINEER (TSE) TROUBLESHOT THE ISSUE WITH THE CUSTOMER OVER THE TELEPHONE. THE CUSTOMER REPORTED TO HAVE REPLACED THE GRAPHIC USER INTERFACE (GUI) TO BREATH DELIVERY UNIT (BDU) CABLE, WHICH RESOLVED THE MALFUNCTION. CUSTOMER CONDUCTED FINAL TESTING, AND CALIBRATIONS. THE UNIT PASSED ALL TESTS AND CALIBRATIONS, AND IT WAS OBSERVED TO BE OPERATING WITHIN MANUFACTURING SPECIFICATIONS. COVIDIEN REFERENCE # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER IN THE USA THAT AN 840 VENTILATOR GENERATED AN ERROR CODE INDICATING A LOSS OF COMMUNICATION BETWEEN THE GRAPHIC USER INTERFACE (GUI) PRINTED CIRCUIT BOARD (PCB) AND THE BREATH DELIVERY UNIT (BDU). THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387677 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1