BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPACT 754 PORTABLE VENTILATOR SYSTEM

    MDR report key: 2910405 · Received January 4, 2013

    Report

    Report Number
    2242630-2013-00006
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    November 28, 2012
    Report Date
    January 4, 2013
    Manufacturer
    IMPACT INSTRUMENTATION, INC.
    Product Code
    BTL
    PMA / PMN Number
    K931473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    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 TESTING IN A VIBRATION ENVIRONMENT. 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 754 PORTABLE VENTILATOR SYSTEM IN AMBULANCE TRANSPORTATION WHEN THE USER REPORTED THE VENTILATOR SCREEN READ "VENT FAILURE" AND THE VENTILATOR STOPPED WORKING. 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 MANUALLY VENTILATED. 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
    4167 IMPACT 754 PORTABLE VENTILATOR SYSTEM VENTILATOR BTL IMPACT INSTRUMENTATION, INC. 754 NA

    Patients

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