BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPACT 754 PORTABLE VENTILATOR SYSTEM

    MDR report key: 2984868 · Received February 24, 2013

    Report

    Report Number
    2242630-2012-00152
    Event Type
    Injury
    Date Received
    February 24, 2013
    Date of Event
    October 18, 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
    IN, 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 CONFIRMED (BATTERY TEST WAS OK) HOWEVER, A POWER ISSUE WAS EVIDENT. THE FAILURE COULD NOT BE LINKED TO A SPECIFIC COMPONENT FAILURE. A COMPLETE PERIOD MAINTENANCE PROCEDURE WAS PERFORMED AND THE ISSUE WAS CORRECTED THROUGH THIS PROCEDURE. THE UNIT WAS RETURNED TO THE END USER AFTER IT TESTED WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    PT WAS BEING SUPPORTED ON AN IMPACT 754 PORTABLE VENTILATOR SYSTEM AND THE END USER REPORTED THE DEVICE BATTERY FAILED AND THE UNIT WOULD NOT FUNCTION USING THE POWER CORD. THE END USER WAS CONTACTED BUT NO RESPONSE WAS RECEIVED REGARDING ADDITIONAL DETAILS OF THE EVENT. IT IS NOT KNOWN IF THE PT WAS MANUALLY VENTILATED OR VENTILATED WITH A BACK-UP AUTOMATIC VENTILATOR. 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, WE HAVE SUBMITTED THIS AS A SERIOUS INJURY EVENT BECAUSE BACK-UP VENTILATION EQUIPMENT MAY HAVE BEEN USED AND IT MAY HAVE BECOME NECESSARY TO USE THIS EQUIPMENT IN ORDER TO PRECLUDE PERMANENT IMPAIRMENT OR DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79105 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.