BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPACT 754 PORTABLE VENTILATOR SYSTEM

    MDR report key: 2885161 · Received December 17, 2012

    Report

    Report Number
    2242630-2012-00108
    Event Type
    Injury
    Date Received
    December 17, 2012
    Date of Event
    September 14, 2012
    Report Date
    December 16, 2012
    Manufacturer
    IMPACT INSTRUMENTATION, INC.
    Product Code
    BTL
    PMA / PMN Number
    K931473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS TESTED UPON RECEIPT AT IMPACT AND FOUND TO EXHIBIT THE REPORTED PROBLEM. THE DEVICE WAS DISASSEMBLED AND INSPECTED AND THE PC BOARDS WERE FOUND TO BE OUT OF ALIGNMENT. THE UNIT WAS REASSEMBLED, PERIODIC MAINTENANCE WAS PERFORMED INCLUDING CALIBRATION AND BURN-IN AND THE UNIT WAS RETURNED TO THE END USER.

    Description of Event or Problem · 1

    PATIENT WAS BEING SUPPORTED ON AN IMPACT 754 PORTABLE VENTILATOR SYSTEM AND IT WAS REPORTED THAT THE VENTILATOR SHUT DOWN UNEXPECTEDLY. THE END USER REPORTED THERE WAS NO SERIOUS INJURY TO THE PATIENT AS A RESULT OF THE INCIDENT. THOUGH IT WAS REPORTED THAT SERIOUS INJURY TO THE PATIENT DID NOT OCCUR, AND, THOUGH IT WAS NOT REPORTED THAT BACK-UP EQUIPMENT WAS UTILIZED, WE HAVE SUBMITTED THIS AS A SERIOUS INJURY EVENT BECAUSE IT IS ASSUMED THAT INTERVENTION USING BACK-UP VENTILATION EQUIPMENT MAY HAVE BECOME NECESSARY TO PRECLUDE PERMANENT IMPAIRMENT OR DAMAGE DUE TO THE UNEXPECTED DEVICE ACTIVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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