BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 3708418 · Received March 14, 2014

    Report

    Report Number
    8020893-2014-00600
    Event Type
    Injury
    Date Received
    March 14, 2014
    Date of Event
    February 3, 2014
    Report Date
    February 12, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER SUPPORT ENGINEER (CSE) REPLACED THE GRAPHICAL USER INTERFACE (GUI)/ CENTRAL PROCESSING UNITS (CPU) PRINTED CIRCUIT BOARD (PCB), BREATH DELIVERY UNIT PCB, AND UPLOADED SOFTWARE TO THE DEVICE. THE DEVICE WAS THEN TESTED AND PERFORMED ALL CALIBRATIONS: EXTENDED SELF-TEST (EST), SHORT SELF-TEST (SST), O2 SENSOR AND ELECTRICAL SAFETY TESTING. THE DEVICE PASSED ALL TESTING. THE SERVICE HISTORY RECORD (SHR) 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

    SBF HOLDA REPORT WAS RECEIVED FROM THE (B)(6) STATING THAT, DURING PT USE IN A NEUROLOGICAL UNIT WHERE THE PT RECEIVED 1:1 NURSING OBSERVATION, THE GRAPHIC USER INTERFACE (GUI) WENT BLANK AND A BURNING SMELL WAS EMITTED FROM THE BACK OF THE DISPLAY. THE PT WAS MANUALLY VENTILATED AND TRANSFERRED TO A SECOND VENTILATOR. THERE WAS NO HARM OR PT INJURY REPORTED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFO; HOWEVER, NO ADDITIONAL INFO HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154882 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention