BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPACT EAGLE II PORTABLE VENTILATOR SYSTEM

    MDR report key: 2984869 · Received February 24, 2013

    Report

    Report Number
    2242630-2013-00014
    Event Type
    Injury
    Date Received
    February 24, 2013
    Date of Event
    January 22, 2013
    Report Date
    February 22, 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 WAS NOT DUPLICATED. IT WAS ALSO REPORTED THAT THE POWER SWITCH WAS DIFFICULT TO OPERATE WITHOUT THE USE OF A TOOL (WHICH DID NOT APPEAR TO BE RELATED TO THE FAILURE OF THE DEVICE WHILE BEING USED ON A PT). PERIODIC MAINTENANCE, CALIBRATION AND FUNCTIONAL TESTING WAS PERFORMED ALONG WITH REPAIR OF THE POWER SWITCH. THE UNIT WAS RETURNED TO THE END USER AFTER IT TESTED WITHIN SPECIFICATION. THIS CLINICAL SITE HAS PRESENTED IN THE PAST WITH TRAINING ISSUES WHICH MAY HAVE CONTRIBUTED TO THE DEVICE EVENT. ADDITIONAL TRAINING WILL BE PROVIDED ALONG WITH ADDITIONAL PHONE SUPPORT.

    Description of Event or Problem · 1

    IMPACT EAGLE II PORTABLE CRITICAL CARE VENTILATOR SYSTEM WAS FUNCTIONING NORMALLY WHILE SUPPORTING A PT IN THE HOSPITAL EMERGENCY ROOM WHEN IT GAVE AN INTAKE BLOCKAGE ALARM. THE PT WAS MANUALLY VENTILATED UNTIL ANOTHER AUTOMATED VENTILATOR WAS PREPARED FOR USE. 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 MANUAL BACK-UP EQUIPMENT WHILE THE INCIDENT WAS RESOLVED. 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 DEVICE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79104 IMPACT EAGLE II PORTABLE VENTILATOR SYSTEM VENTILATOR CBK IMPACT INSTRUMENTATION, INC. EAGLE 2 NA

    Patients

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