BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPACT 754 PORTABLE VENTILATOR SYSTEM

    MDR report key: 2910410 · Received January 4, 2013

    Report

    Report Number
    2242630-2013-00002
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    October 9, 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
    WV, 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. UNIT WAS RUN FOR A FULL WEEK AND PERFORMED NORMALLY. OPERATION ALSO CHECKED WHILE RUNNING IN A VIBRATION ENVIRONMENT WITH NO FAILURES NOTED. 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 PORTABLE VENTILATOR SYSTEM WHILE IN THE HOSP EMERGENCY ROOM. IT WAS REPORTED THAT THE ENTIRE VENTILATOR SCREEN STARTED FLASHING. 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 SWITCHED TO A BACK-UP VENTILATOR. 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
    5320 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.