BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 3893985 · Received June 9, 2014

    Report

    Report Number
    8020893-2014-01385
    Event Type
    Injury
    Date Received
    June 9, 2014
    Date of Event
    January 1, 2014
    Report Date
    May 14, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN TECHNICAL SUPPORT ENGINEER (TSE) TROUBLESHOT THE ISSUE WITH THE CUSTOMER OVER THE TELEPHONE, AND RECOMMENDED TO RUN THE UNIT FOR 48 HOURS IN AN ATTEMPT TO DUPLICATE THE ISSUE. THE CUSTOMER REPORTED THAT HE RAN THE DEVICE FOR 3 DAYS, AND WAS UNABLE TO DUPLICATE THE MALFUNCTION. HE VERIFIED THAT THERE WERE NO KINKS IN THE SOLENOID 1 TUBING, PERFORMED ALL CALIBRATIONS AND EXTENDED SELF-TESTING. THE VENTILATOR PASSED ALL TESTS AND CALIBRATIONS, AND IT WAS OPERATING WITHIN MANUFACTURING SPECIFICATIONS. COVIDIEN REFERENCE (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER IN THE USA THAT AN 840 VENTILATOR STOPPED CYCLING DURING USE ON A PATIENT, WHO WAS TRANSFERRED TO AN ALTERNATIVE VENTILATOR. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336160 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention