BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPACT 754 PORTABLE VENTILATOR SYSTEM

    MDR report key: 3259095 · Received July 30, 2013

    Report

    Report Number
    2242630-2013-00057
    Event Type
    Injury
    Date Received
    July 30, 2013
    Date of Event
    April 11, 2013
    Report Date
    July 22, 2013
    Manufacturer
    IMPACT INSTRUMENTATION, INC.
    Product Code
    BTL
    PMA / PMN Number
    K931473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS TESTED UPON RECEIPT AT IMPACT AND, WHILE THE DEVICE OPERATED NORMALLY UPON INPUT TESTING, AN INTERMITTENT CONNECTION TO THE COMPRESSOR WAS IDENTIFIED ALONG WITH CORROSION ON THE CONNECTOR TO THE MOTOR DRIVE PCB. THE CONNECTOR AND THE MOTOR DRIVE PCB WERE REPLACED. PREVENTIVE MAINTENANCE, CALIBRATION, BURN-IN AND OUTPUT TESTING WERE PERFORMED. THE UNIT WAS RETURNED TO THE END USE AFTER IT TESTED WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    THE PATIENT WAS BEING PREPARED FOR TRANSPORT BETWEEN HEALTHCARE FACILITIES AND WAS BEING SUPPORTED BY AN IMPACT 754 PORTABLE VENTILATOR IN THE HOSPITAL FOR LESS THAN A MINUTE WHEN THE VENTILATOR WAS REPORTED TO GIVE A "NO GAS, COMPRESSOR FAILURE, CODE 2" ALARM. THE PATIENT WAS PLACED BACK ON THE FACILITIES VENTILATOR UNTIL ANOTHER AUTOMATED PORTABLE VENTILATOR COULD BE OBTAINED FROM ANOTHER TRANSPORT VEHICLE. THE VENTILATOR WAS REPORTED TO ALARM; HOWEVER, IT WAS NOT REPORTED THAT THE DEVICE FAILED. THE ACTIONS TAKEN WERE BASED ON THE ALARMS EXHIBITED BY THE VENTILATOR. THE END USER REPORTED THERE WAS NO ADVERSE EVENTS TO THE PATIENT AS A RESULT OF THE INCIDENT. THOUGH IT WAS REPORTED THAT SERIOUS INJURY TO THE PATIENT DID NOT OCCUR, IT WAS REPORTED THAT THE UNEXPECTED BEHAVIOR OF THE VENTILATOR CAUSED THE NEED TO TRANSFER THE PATIENT BACK TO THE FACILITY VENTILATOR AND OBTAIN AN ADDITIONAL BACK-UP AUTOMATED VENTILATOR. THIS EVENT IS BEING SUBMITTED AS A SERIOUS INJURY EVENT BECAUSE THE USE OF BACK-UP VENTILATION WAS NECESSARY TO PRECLUDE PERMANENT IMPAIRMENT OR DAMAGE DUE TO THE DEVICE INCIDENT. NOTE: TWO PATIENT EVENTS WERE REPORTED DUE TO THIS FAILURE - SEE ALSO 2242630-2013-00058.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354894 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.