BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840

    MDR report key: 2233356 · Received August 31, 2011

    Report

    Report Number
    2233356
    Event Type
    Malfunction
    Date Received
    August 31, 2011
    Date of Event
    August 15, 2011
    Report Date
    August 24, 2011
    Manufacturer
    COVIDIEN PURITAN BENNETT
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    THE MECHANICAL VENTILATOR WAS ON A PATIENT; ALARMED; AND THE SCREEN WENT BLANK. THE SAFETY VALVE WAS OPEN AND THE VENTILATOR SEEMED TO BE DISCHARGING AIR WHEN REMOVED FROM PATIENT.======================MANUFACTURER RESPONSE FOR VENTILATOR, PURITAN BENNETT (PER SITE REPORTER)======================(B) (4) CLINICAL BIOMEDICAL ENGINEERING CHECKED DIAGNOSTIC LOG FOR ERRORS AND FOUND UT0002(BUS ERROR/ACCESS FAULT)FAILURE AND XP0129 (APPLICATION OS BOOT)FAILURE.(B)(4) FIELD SERVICE TECHNICIAN FROM COVIDIEN CAME TO DO REPAIR AND HE FOUND THE GUI CPU TO BE FAULTY. HE REPLACED GUI CPU AND DID TESTING. REFER TO ATTACHED DOCUMENT FOR WORK PERFORMED AND TESTING RESULTS. HE GAVE THE OKAY FOR USE. (B)(4) DOCUMENTED, ATTACHED DOCUMENTATION, CLOSED OUT WORK ORDER, AND RETURNED VENTILATOR TO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 840 VENTILATOR, CONTINUOUS, FACILITY USE CBK COVIDIEN PURITAN BENNETT 840 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *