BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRATION 5I VENTILATOR SYSTEM

    MDR report key: 3899293 · Received May 21, 2014

    Report

    Report Number
    3006135941-2014-00002
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 15, 2014
    Manufacturer
    EVENT MEDICAL LTD.
    Product Code
    CBK
    PMA / PMN Number
    K130178
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    VENTILATOR POWER FAILED, SUDDENLY TURNED OFF WHILE IN USE WITH PT. NO REPORT OF ANY INJURY TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303935 INSPIRATION 5I VENTILATOR SYSTEM CONTINUOUS VENTILATOR CBK EVENT MEDICAL LTD. 5I

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention