BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3810712 · Received March 21, 2014

    Report

    Report Number
    8020893-2014-00671
    Event Type
    Malfunction
    Date Received
    March 21, 2014
    Date of Event
    February 1, 2014
    Report Date
    February 20, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PU
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY HAS NOT REQUESTED REPAIR OF THE DEVICE AT THIS TIME. THE DEVICE RECEIVED VERY LOW USAGE OVER THE AGE OF THE DEVICE, REGISTERING LESS THAN 500 HOURS. SHOULD THE USER FACILITY REQUEST REPAIR OR PROVIDE ADD'L INFO, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM THE USA WITH INFO THAT THE DEVICE EXPERIENCED A GUI INOP ALERT. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169633 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PU 840

    Patients

    Seq Age Sex Outcome Treatment
    1