BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3813524 · Received March 26, 2014

    Report

    Report Number
    8020893-2014-00695
    Event Type
    Malfunction
    Date Received
    March 26, 2014
    Date of Event
    February 1, 2014
    Report Date
    February 24, 2014
    Manufacturer
    COVIDIEN, FORMERLYNELLCOR PURITAN BENNETT IRELAND
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICAL SUPPORT ENGINEERING INFORMED THE USER FACILITY THAT THE DEVICE REQUIRED REPLACEMENT OF THE BREATH DELIVERY (BD) CENTRAL PROCESSING UNIT (CPU). NO FURTHER INFO HAS BEEN RECEIVED FROM THE USER FACILITY. SHOULD ADD'L INFO BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE HISTORY RECORD FOR THIS DEVICE WAS REVIEWED FOR SIMILAR COMPLAINT MODES. NO RELEVANT COMPLAINT MODES WERE FOUND IN THE DEVICE SERVICE HISTORY RECORD. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED. (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM THE USA INDICATING THAT THE DEVICE EXPERIENCED ERROR CODES ZB0059 (LOSS OF BD COMMUNICATION), LB0076 (TASK MONITOR) AND KP0087 (UNEXPECTED RESET UMPIRE TEST). THERE WAS NO PT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176913 840 VENTILATOR CBK COVIDIEN, FORMERLYNELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1