BEUDAMED
    FDA Adverse Event Injury Summary report: N

    980 VENTILATOR

    MDR report key: 6513666 · Received April 22, 2017

    Report

    Report Number
    8020893-2017-05777
    Event Type
    Injury
    Date Received
    April 22, 2017
    Report Date
    March 24, 2017
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K131252
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 FOUND NO NOTABLE CONDITIONS AND 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 GENERATED AN INOPERABLE 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 REPORTED EVENT. THE SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND FOUND A DIAGNOSTIC CODE IN THE MEMORY LOGS RELEVANT TO THE REPORTED ISSUE. THE SE REPLACED THE BREATH DELIVERY (BD) POWER CONTROLLER/DISTRIBUTION PRINTED CIRCUIT BOARD (PCB). 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
    295740 980 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK COVIDIEN 980

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention