BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    980 VENTILATOR

    MDR report key: 6072247 · Received November 2, 2016

    Report

    Report Number
    8020893-2016-02954
    Event Type
    Malfunction
    Date Received
    November 2, 2016
    Report Date
    October 10, 2016
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K131252
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COVIDIEN SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND VERIFIED THE REPORTED ISSUE. THE SE FOUND THE CONNECTION TO THE BREATH DELIVERY BACKPLANE PRINTED CIRCUIT BOARD (PCB) LOOSE. THE SE RECONNECTED THE CABLE AND PERFORMED EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, A 980 VENTILATOR WOULD GENERATE A CONTINUOUS ALARM WHEN PLUGGED INTO ALTERNATE CURRENT (AC). THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME THE EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725755 980 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN 980

    Patients

    Seq Age Sex Outcome Treatment
    1