BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPACT 73X PORTABLE VENTILATOR SYSTEM

    MDR report key: 4178528 · Received October 16, 2014

    Report

    Report Number
    2242630-2014-00006
    Event Type
    Malfunction
    Date Received
    October 16, 2014
    Date of Event
    August 22, 2013
    Report Date
    August 18, 2014
    Manufacturer
    IMPACT INSTRUMENTATION, INC.
    Product Code
    BTL
    PMA / PMN Number
    K051476
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    (B)(4). THIS SYSTEM WAS RETURNED TO THE MANUFACTURE FOR NORMAL PREVENTATIVE MAINTENANCE. DURING THE EVALUATION OF THIS SYSTEM: ONCE OPENED, INSPECTION OF THE INTERIOR COMPONENTS SHOWED DISCOLORATION AND APPEAR TO HAVE BEEN OVERHEATED OR EXPOSED TO A CORROSIVE. THIS SYSTEM IS BEYOND REPAIR. THIS INFO WAS COMMUNICATED TO THE OWNER OF THE DEVICE. THIS UNIT IS UNREPAIRABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658364 IMPACT 73X PORTABLE VENTILATOR SYSTEM VENTILATOR BTL IMPACT INSTRUMENTATION, INC. 73X NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NONE REPORTED BY THE OPERATOR