BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3770343 · Received March 7, 2014

    Report

    Report Number
    8020893-2014-00568
    Event Type
    Malfunction
    Date Received
    March 7, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 28, 2014
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Removal / Correction Number
    Z-0611-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    A COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) REPLACED THE O2 CELL AND INSTALLED AK REVISION SOFTWARE. THE CSE PERFORMED CALIBRATIONS, SHORT SELF-TEST (SST) AND EXTENDED SELF-TEST (EST). ALL TESTS PASSED PER MFG SPECIFICATIONS. THE SERVICE HISTORY RECORD WAS REVIEWED FOR SIMILAR COMPLAINT MODE. NO RELEVANT COMPLAINT MODES WERE FOUND IN THE DEVICE SERVICE HISTORY RECORD. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED. FIELD ACTION ASSOCIATED WITH THIS ISSUE WAS ISSUED (B)(4) 2013. (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM THE USA THAT ON AN UNSPECIFIED DATE, THE BIOMEDICAL ENGINEER WAS UNABLE TO UPLOAD SOFTWARE TO THE DEVICE AND EXPERIENCED A XB0069 CODE. THE XB0069 IS A MONITORING TASK THAT RUNS ON THE GUI (GRAPHIC USER INTERFACE) CENTRAL PROCESSING UNIT (CPU) PROCESSOR. IF THE GUI MONITORING TASK HAS DETERMINED THAT THE PRESSURE EXCEEDS THE CLINICIAN SET PRESSURE LIMIT AND THE BDU HAS NOT TRIGGERED A HIGH PRESSURE PATIENT ALARM, THEN THE XB0069 CODE IS INITIATED. ONCE THE XB0069 IS INITIATED THE PB840 VENTILATOR SYSTEM ENTERS A VENTILATOR INOPERATIVE CONDITION WHICH TRIGGERS THE SAFETY VALVE TO OPEN AND INITIATES A CONTINUOUS HIGH PRIORITY ALARM. WHEN THE SAFETY VALVE IS OPEN, THE VENTILATOR OPENS A PATH FOR THE PATIENT TO BREATHE ROOM AIR SPONTANEOUSLY, ALTHOUGH POSITIVE PRESSURE VENTILATION IS NO LONGER PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140116 840 VENTILATOR CBK VENTILATOR CBK COVIDIEN 840 NA

    Patients

    Seq Age Sex Outcome Treatment
    1