BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3813525 · Received March 26, 2014

    Report

    Report Number
    8020893-2014-00705
    Event Type
    Malfunction
    Date Received
    March 26, 2014
    Date of Event
    January 29, 2014
    Report Date
    February 25, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER SERVICE ENGINEER (CSE) VERIFIED THE EVENT. THE CSE INSPECTED THE DEVICE AND REPLACED THE ANALOG INTERFACE (AI) PRINTED CIRCUIT BOARD (PCB). THE CSE PERFORMED ALL CALIBRATIONS, THE EXTENDED SELF-TEST (EST), SHORT SELF-TEST (SST) AND THE PERFORMANCE VERIFICATION TEST (PVT). THE DEVICE OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS. 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 USE INDICATING THAT THE DEVICE STOPPED CYCLING. THE DEVICE EXPERIENCED ERROR CODES KP0009 (ROLLING THUNDER TEST) AND DT0002 (BUS ERROR/ACCESS FAULT). THE DEVICE WAS NOT IN USE ON A PT AT THE TIME OF THE EVENT. NO ADD'L INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176755 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1