BEUDAMED
    FDA Adverse Event Injury Summary report: N

    980 VENTILATOR

    MDR report key: 6718566 · Received July 17, 2017

    Report

    Report Number
    8020893-2017-06965
    Event Type
    Injury
    Date Received
    July 17, 2017
    Report Date
    June 19, 2017
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K131252
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BREATH DELIVERY (BD) POWER DISTRIBUTION PRINTED CIRCUIT BOARD (PCB) AND A BD CONTROLLER PCB WERE RETURNED TO COVIDIEN/MEDTRONIC¿S PRODUCT ANALYSIS. A VISUAL INSPECTION OF THE RETURNED COMPONENT WAS PERFORMED, NO NOTABLE CONDITIONS WERE FOUND. THE RETURNED COMPONENTS WERE INSTALLED INTO A TEST VENTILATOR FOR ANALYSIS; NO ERRORS WERE RECORDED IN THE DIAGNOSTIC LOGS. AN INVESTIGATION WAS PERFORMED AND THE PRODUCT ANALYSIS TECHNICIAN REPORTED THAT NO FAULT WAS FOUND. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, A 980 VENTILATOR EXPERIENCED A BACKGROUND MALFUNCTION AND THE VENTILATOR EXPERIENCED THE BACK-UP VENTILATION CONDITION. 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 REPORTED EVENT. THE SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND FOUND DIAGNOSTIC CODES RELEVANT TO THE REPORTED INCIDENT RECORDED IN THE VENTILATORS MEMORY LOGS. THE SE REPLACED THE POWER CONTROL AND POWER DISTRIBUTION BOARD. THE SE PERFORMED CALIBRATIONS AND EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497783 980 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK COVIDIEN 980

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention