BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPACT EAGLE II PORTABLE VENTILATOR SYSTEM

    MDR report key: 2910388 · Received January 4, 2013

    Report

    Report Number
    2242630-2013-00005
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    November 13, 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
    ID, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS TESTED UPON RECEIPT AT IMPACT AND THE REPORTED PROBLEM COULD NOT BE DUPLICATED. EXTENSIVE DISCUSSIONS WERE CONDUCTED WITH THE END USER AND IMPACT'S QA AND ENGINEERING DEPARTMENTS TO RULE-OUT INTERACTION WITH CT EQUIPMENT AND TO INVESTIGATE POSSIBLE ROOT CAUSES. ROOT CAUSE WAS POSSIBLY LINKED TO USER TRAINING AND ADDITIONAL TRAINING BY IMPACT STAFF WAS REQUESTED FOR THE HOSP. SIMULATED USE TESTING WAS PERFORMED INCLUDING BURN-IN AND FUNCTIONAL TESTING 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 EAGLE II PORTABLE CRITICAL CARE VENTILATOR SYSTEM IN THE HOSP CT AREA WHEN THE USER REPORTED THAT THE VENTILATOR GAVE A "LOW GAS" OR "LOW FIO2" (RECORDING OF THE ERROR CODES WAS NOT DONE AT THE TIME OF THE EVENT) WHILE SWITCHING FROM TANK O2 TO WALL O2 AND IT WAS BELIEVED THAT THE DEVICE FAILED TO DELIVER BREATHS THEN STOPPED WORKING COMPLETELY. 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 TEMPORARILY MANUALLY VENTILATED THEN A BACK-UP AUTOMATED VENTILATOR WAS USED TO SUPPORT THE PT. 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
    5476 IMPACT EAGLE II PORTABLE VENTILATOR SYSTEM VENTILATOR CBK IMPACT INSTRUMENTATION, INC. EAGLE II NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R NONE REPORTED BY THE OPERATOR.