BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPACT EMV+ PORTABLE VENTILATOR SYSTEM

    MDR report key: 2910389 · Received January 4, 2013

    Report

    Report Number
    2242630-2013-00003
    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
    TX, 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. PERIODIC MAINTENANCE WAS PERFORMED INCLUDING CALIBRATION AND BURN-IN AND THE UNIT WAS RETURNED TO THE END USER AFTER IT TESTED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    IMPACT SERIES 731 EMV+ PORTABLE VENTILATOR SYSTEM WAS BEING SET-UP FOR USE ON A PT WHEN THE USER REPORTED THAT THE SCREEN FROZE AND THE VENTILATOR WAS UNRESPONSIVE. 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 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
    5315 IMPACT EMV+ PORTABLE VENTILATOR SYSTEM VENTILATOR CBK IMPACT INSTRUMENTATION, INC. EMV+ NA

    Patients

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