BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 3851112 · Received May 22, 2014

    Report

    Report Number
    8020893-2014-01229
    Event Type
    Injury
    Date Received
    May 22, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 24, 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
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT REPLACED THE ANALOG INTERFACE (AI) PRINTED CIRCUIT BOARD (PCB). THE UNIT PASSED ALL TESTING AN OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS AT THE TIME OF SERVICE. THE RETURNED ANALOG INTERFACE PCB (AI PCB) WAS REPORTED TO HAVE EXHIBITED THE FOLLOWING FAILURE: ERROR CODE KB0016. A FAILURE INVESTIGATION TEST VENTILATOR WAS USED FOR THIS INVESTIGATION. THE FUNCTIONALITY OF THE TEST VENTILATOR WAS VERIFIED BY SUCCESSFULLY RUNNING THE FOLLOWING TEST: POST (POWER ON SELF TEST), CALIBRATIONS, EST (EXTENDED SELF TEST) AND SST (SHORT SELF TEST) AS DETAILED IN THE 840 VENTILATOR SERVICE MANUAL. A VISUAL INSPECTION WAS CARRIED OUT ON THE RETURNED COMPONENT, NO ANOMALIES WERE OBSERVED. THE AI PCB WAS ATTACHED TO THE FAILURE INVESTIGATION TEST VENTILATOR FOR ANALYSIS. THE VENTILATOR WAS POWERED UP. THE VENTILATOR PASSED POST AND NO ERRORS WERE RECORDED IN THE DIAGNOSTIC LOGS. RAN CALIBRATION, EST AND SST PROCEDURES WITHOUT ANY ERRORS. PUT THE VENTILATOR INTO VENTILATION MODE FOR MINIMUM OF 24 HOURS. ON REVIEW OF THE VENTILATOR DIAGNOSTICS LOGS NO ERRORS WERE OBSERVED. NO ALARMS WERE OBSERVED WHILE ON REST. CONCLUSION: NO FAULT FOUND. (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION FROM A CUSTOMER IS THE USA STATING THAT AN 840 VENTILATOR STOPPED CYCLING WHILE IN USE ON A PATIENT. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306562 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention