BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRATION LS VENTILATOR SYSTEM

    MDR report key: 4202652 · Received August 8, 2014

    Report

    Report Number
    3006135941-2014-00004
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    December 14, 2013
    Report Date
    August 6, 2014
    Manufacturer
    EVENT MEDICAL LTD.
    Product Code
    CBK
    PMA / PMN Number
    K051550
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    DISTRIBUTOR WAITED 8 MONTHS BEFORE REPORTING THIS INCIDENT TO EVENT MEDICAL. THAT IS WHY THERE IS SUCH A LARGE DISCREPANCY BETWEEN THE EVENT DATE AND REPORT DATE.

    Description of Event or Problem · 1

    PATIENT STARTED ON VENT SUCCESSFULLY - HOURS LATER PRESSURE GRAPH WOULD SPIKE AND PATIENT NOT BEING VENTED - MANUALLY RESUSCITATED, PUT BACK ON, BUT THIS OCCURRED SEVERAL TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473034 INSPIRATION LS VENTILATOR SYSTEM CONTINUOUS VENTILATOR CBK EVENT MEDICAL LTD. LS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention