BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3800605 · Received February 11, 2014

    Report

    Report Number
    8020893-2014-00314
    Event Type
    Malfunction
    Date Received
    February 11, 2014
    Date of Event
    January 14, 2014
    Report Date
    January 14, 2014
    Manufacturer
    COVIDIEN, FORMELRY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Removal / Correction Number
    Z-0611-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND VERIFIED THE CUSTOMER REPORTED PROBLEM. THE CSE PERFORMED 840 SOFTWARE FIELD ACTION. THE UNIT PASSED EXTENDED SELF-TESTING. FIELD ACTION ASSOCIATED WITH THIS ISSUE WAS ISSUED (B)(4) 2013.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION OF VENTILATOR BEING INOPERABLE. THE MALFUNCTION DID NOT OCCUR DURING PT USE. RE-EVALUATION OF THE COMPLAINT IDENTIFIED THE XB0069 WAS FOUND TO BE PRESENT WITHIN THE DIAGNOSTIC LOG OF THE DEVICE ASSOCIATED WITH THIS COMPLAINT. THE XB0069 IS A MONITORING TASK THAT RUNS ON THE GUI (GRAPHIC USER INTERFACE) 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 PT 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 PT TO BREATH ROOM AIR SPONTANEOUSLY, ALTHOUGH POSITIVE PRESSURE VENTILATION IS NO LONGER PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90105 840 VENTILATOR CBK: VENTILATOR, CONTINUOUS, FACILITY CBK COVIDIEN, FORMELRY NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1