BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 6802186 · Received August 17, 2017

    Report

    Report Number
    8020893-2017-07497
    Event Type
    Malfunction
    Date Received
    August 17, 2017
    Date of Event
    July 14, 2017
    Report Date
    May 2, 2018
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K151252
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: ADDITIONAL INFORMATION WAS RECEIVED ON 2018-APR-25 REGARDING THE EVALUATION AND REPAIR STATUS. H2 UNIQUE IDENTIFIER (UDI) # (B)(4) CORRECTION: PMA / 510(K) # TO K151252 D4 CATALOG # TO 4-840120DIJJ-JP H2 DEVICE EVALUATION: EVALUATION CODES UPDATED. EVALUATION SUMMARY: A SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND REPLACED THE GRAPHICAL USER INTERFACE (GUI) FLEX CIRCUIT CABLE. THE UNIT PASSED TESTING AND OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    AT THIS TIME, MEDTRONIC HAS NOT RECEIVED THE SUSPECT DEVICE/COMPONENT FROM THE CUSTOMER FOR EVALUATION. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. 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 BLANK UPPER DISPLAY. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME OF THE REPORTED INCIDENT. IT WAS REPORTED THAT THE DISPLAY STARTED WORKING AGAIN WHEN THE GRAPHICAL USER INTERFACE (GUI) WAS "SHOCKED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580239 840 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1