BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPACT EMV+ PORTABLE VENTILATOR SYSTEM

    MDR report key: 2910404 · Received January 4, 2013

    Report

    Report Number
    2242630-2013-00007
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    December 3, 2012
    Report Date
    January 4, 2013
    Manufacturer
    IMPACT INSTRUMENTATION, INC.
    Product Code
    CBK
    PMA / PMN Number
    K103318
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS TESTED UPON RECEIPT AT IMPACT AND THE REPORTED PROBLEM COULD NOT BE DUPLICATED. SIMULATED USE TESTING WAS PERFORMED INCLUDING RUNNING THE UNIT IN MULTIPLE SETTINGS WITH O2 AND AT 60% FIO2. BURN-IN AND FUNCTIONAL TESTING WAS ALSO COMPLETED AND THE UNIT WAS RETURNED TO THE END USER AFTER IT TESTED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    PT WAS BEING SUPPORTED BY AN IMPACT EMV+ PORTABLE VENTILATOR SYSTEM WHILE IN THE HOSPITAL SETTING WHEN THE USER REPORTED THE VENTILATOR STOPPED DELIVERING GAS (AS TESTED BY PLACING A HAND OVER THE CIRCUIT). THE END USER REPORTED THERE WAS NO SERIOUS INJURY TO THE PT AS A RESULT OF THE INCIDENT. THOUGH IT WAS REPORTED THAT SERIOUS INJURY TO THE PT DID NOT OCCUR, IT WAS REPORTED THAT THE PT WAS VENTILATED USING BACK-UP EQUIPMENT. WE HAVE SUBMITTED THIS AS A SERIOUS INJURY EVENT BECAUSE BACK-UP VENTILATION EQUIPMENT WAS NECESSARY TO PRECLUDE PERMANENT IMPAIRMENT OR DAMAGE DUE TO THE UNEXPECTED DEVICE ACTIVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5318 IMPACT EMV+ PORTABLE VENTILATOR SYSTEM VENTILATOR CBK IMPACT INSTRUMENTATION, INC. EMV+ NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NONE REPORTED BY THE OPERATOR.