BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 6667093 · Received June 26, 2017

    Report

    Report Number
    8020893-2017-06720
    Event Type
    Injury
    Date Received
    June 26, 2017
    Report Date
    June 25, 2018
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K151252
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: PMA / 510(K) # TO K151252. EVALUATION: THE KEYBOARD PRINTED CIRCUIT BOARD (PCB) WAS RETURNED TO MEDTRONIC¿S PRODUCT ANALYSIS LABORATORY. A VISUAL INSPECTION WAS PERFORMED AND NO ANOMALIES WERE OBSERVED. AN INVESTIGATION WAS PERFORMED AND NO ERRORS WERE RECORDED IN THE DIAGNOSTIC LOGS DURING TESTING. NO FAULT WAS FOUND WITH THE RETURNED KEYBOARD PCB. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    UPDATE TO EVALUATION CODE-RESULT. DEVICE EVALUATION SUMMARY: A SECOND KEYBOARD WAS RETURNED TO MEDTRONIC FOR FAILURE INVESTIGATION. A VISUAL INSPECTION OF THE RETURNED PART WAS CONDUCTED AND THE FOLLOWING WAS OBSERVED: THERE WAS EVIDENCE OF CONTAMINATION AS A RESULT OF FLUID INGRESS ON THE PCBA NEAR THE Q4 TRANSISTOR AND THE R10 RESISTOR. THE PART WAS ATTACHED TO THE FAILURE INVESTIGATION TEST VENTILATOR FOR ANALYSIS. THE VENTILATOR WAS POWERED UP WITH NO ERRORS RECORDED IN THE DIAGNOSTIC LOGS. THE VENTILATOR WAS PUT INTO NORMAL VENTILATION MODE AND RAN SUCCESSFULLY IN VENTILATION MODE FOR 72 HOURS. A REVIEW OF THE VENTILATOR DIAGNOSTIC LOGS REVEALED THAT NO ERRORS AND THERE WERE NO UNEXPECTED ALARMS OBSERVED DURING THE RUN PERIOD. WHILE NO FAULT WAS FOUND DURING THE TESTING OF THIS PART, CONTAMINATION OF THIS TYPE CAN CAUSE INTERMITTENT FAULTS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE IN USE ON A PATIENT, THE VENTILATOR SCROLL KNOB STOPPED WORKING ON AN 840 VENTILATOR. 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. THE SERVICE ENGINEER (SE) WAS ABLE TO DUPLICATE THE REPORTED ISSUE AND REPLACED THE GUI (GRAPHICAL USER INTERFACE) KEYBOARD ASSEMBLY. THE UNIT PASSED ALL TESTING AND OPERATED WITHIN THE MANUFACTURER'S SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448472 840 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention