BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 6421748 · Received March 21, 2017

    Report

    Report Number
    8020893-2017-05329
    Event Type
    Malfunction
    Date Received
    March 21, 2017
    Report Date
    April 9, 2018
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K151252
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REPAIRED AND THE REPORTED ISSUE WAS ISOLATED TO INTERFACE BETWEEN THE DEVICE AND THE FAILED COMPONENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CORRECTION: PMA / 510(K) # TO K151252 SHOULD HAVE BEEN 2017-04-26 ON FOLLOW UP REPORT 1. DATE SHOULD HAVE BEEN 2017 (B)(6) ON FOLLOW UP REPORT 1. CORRECTED EVALUATION RESULTS CODE CORRECTED EVALUATION SUMMARY TO: THE REPLACED TOUCH-FRAME PRINTED CIRCUIT BOARD (PCB) WAS RETURNED TO MEDTRONIC'S PRODUCT ANALYSIS LABORATORY. UPON VISUAL INSPECTION, AREAS OF CONTAMINATION WERE FOUND ON THE PCB. AN INVESTIGATION WAS PERFORMED AND THE REPORTED ISSUE WAS VERIFIED. THE IDENTIFIED ROOT CAUSE OF THE REPORTED ISSUE WAS ISOLATED TO TOUCH-FRAME CONTAMINATION AS A RESULT OF FLUID INGRESS. ADDITIONAL INFORMATION: UDI (B)(6) WAS ADDED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, AN 840 VENTILATOR HAD A TOUCH SCREEN BLOCKED. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME THE MALFUNCTION OCCURRED. THE SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND REPLACED THE GRAPHICAL USER INTERFACE (GUI) TOUCH FRAME PRINTED CIRCUIT BOARD (PCB). THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204912 840 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1