BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3983142 · Received July 3, 2014

    Report

    Report Number
    8020893-2014-01575
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 5, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND REVIEWED THE MEMORY LOGS, THERE WERE NO ERRORS TO SUPPORT THE REPORTED PROBLEM. THE CSE COULD NOT DUPLICATE THE ALLEGED EVENT. THE CSE RAN THE VENTILATOR IN NORMAL OPERATION AND UNPLUGGED FROM AC POWER SEVERAL TIMES, VENTILATION CONTINUED AS SET. THE CSE RAN ALL CALIBRATIONS, SHORT SELF TEST, EXTENDED SELF TEST, ELECTRICAL SAFETY AND PERFORMANCE VERIFICATION TESTING. ALL TESTS PASSED PER THE MANUFACTURER'S SPECIFICATIONS AT THE TIME OF SERVICE. COVIDIEN REFERENCE: (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION STATING THAT WHILE IN USE ON A PATIENT AN 840 VENTILATOR STOPPED CYCLING WHEN THE ALTERNATE CURRENT (AC) PLUG WAS ACCIDENTALLY UNPLUGGED. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392194 840 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention