BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPACT 754 PORTABLE VENTILATOR SYSTEM

    MDR report key: 2984866 · Received February 24, 2013

    Report

    Report Number
    2242630-2013-00010
    Event Type
    Injury
    Date Received
    February 24, 2013
    Date of Event
    December 19, 2012
    Report Date
    February 22, 2013
    Manufacturer
    IMPACT INSTRUMENTATION, INC.
    Product Code
    BTL
    PMA / PMN Number
    K931473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS TESTED UPON RECEIPT AT IMPACT AND THE REPORTED PROBLEM WAS NOT DUPLICATED. PERIODIC MAINTENANCE INCLUDING INSPECTION OF THE INTERNAL COMPONENTS, CALIBRATION AND FUNCTIONAL TESTING WAS PERFORMED. NO SPECIFIC COMPONENT FAILURE COULD BE IDENTIFIED DURING THE SERVICE INVESTIGATION. THE UNIT WAS RETURNED TO THE END USER AFTER IT TESTED WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    PT WAS BEING SUPPORTED BY AN IMPACT 754 PORTABLE VENTILATOR SYSTEM ON TRANSPORT FROM A HOSPITAL EMERGENCY ROOM TO ANOTHER HOSPITAL. THE END USER REPORTED THAT THE DEVICE GAVE APPROXIMATELY 5 BREATHS THEN GAVE A CONTINUOUS "HIGH PRESSURE" ALARM. THE DEVICE COULD NOT BE RECOVERED. THE PT WAS MANUALLY VENTILATED UNTIL COMPLETION OF THE TRANSPORT. 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. 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
    79109 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.