BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 6428745 · Received March 23, 2017

    Report

    Report Number
    8020893-2017-05371
    Event Type
    Injury
    Date Received
    March 23, 2017
    Report Date
    November 22, 2017
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: AN 840 VENTILATOR WAS RETURNED TO COVIDIEN/ MEDTRONIC¿S PRODUCT ANALYSIS. A VISUAL INSPECTION OF THE VENTILATOR WAS PERFORMED, NO NOTABLE CONDITIONS WERE FOUND. THE VENTILATOR WAS TESTED FOR FUNCTIONALITY AND THE DIAGNOSTIC LOGS WERE REVIEWED. 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 840 VENTILATOR GENERATED AN INOPERABLE ERROR MESSAGE. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR. INFORMATION REGARDING THE INTERVENTION TAKEN ON THE BEHALF OF THE PATIENT AND PATIENT OUTCOME HAS NOT BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209680 840 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention