BEUDAMED
    FDA Adverse Event Injury Summary report: N

    980 VENTILATOR

    MDR report key: 6530274 · Received April 28, 2017

    Report

    Report Number
    8020893-2017-05873
    Event Type
    Injury
    Date Received
    April 28, 2017
    Report Date
    November 28, 2017
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K131252
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: A BATTERY WAS RETURNED TO COVIDIEN/ MEDTRONIC¿S PRODUCT ANALYSIS. A VISUAL INSPECTION OF THE RETURNED COMPONENT WAS PERFORMED, NO NOTABLE CONDITIONS WERE FOUND. THE RETURNED COMPONENT WAS INSTALLED INTO A TEST VENTILATOR FOR ANALYSIS AND FUNCTIONALITY TESTING WAS PERFORMED. THE DIAGNOSTIC LOGS WERE REVIEWED AND FOUND TO HAVE AN ANALOG DIGITAL CONVERTER (ADC) VOLTAGE OUT OF RANGE ERROR. AN INVESTIGATION WAS PERFORMED AND THE PRODUCT ANALYSIS TECHNICIAN REPORTED THAT THE REPORTED ISSUE WAS VERIFIED; HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED. 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 GENERATED A BATTERY ERROR MESSAGE. 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 COVIDIEN SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND FOUND A DIAGNOSTIC CODE RELEVANT TO THE REPORTED INCIDENT RECORDED IN THE VENTILATORS MEMORY LOGS. THE SE REPLACED THE BATTERY AND PERFORMED EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311713 980 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK COVIDIEN 980

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention