BEUDAMED
    FDA Adverse Event Injury Summary report: N

    980 VENTILATOR

    MDR report key: 6121945 · Received November 22, 2016

    Report

    Report Number
    8020893-2016-03210
    Event Type
    Injury
    Date Received
    November 22, 2016
    Report Date
    December 21, 2017
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K131252
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND COULD NOT DUPLICATE THE REPORTED EVENT. THE SE PERFORMED EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS PERFORMED AND THE TECHNICIAN FOUND THAT THE REPORTED PROBLEM COULD NOT BE DUPLICATED. NO FAILURE WAS DETECTED. 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 WENT INOPERATIVE. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770389 980 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN 980

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention