BEUDAMED
    FDA Adverse Event Death Summary report: N

    BE 183-XXX (EXACT MODEL NUMBER IS UNKNOWN)

    MDR report key: 1462576 · Received September 1, 2009

    Report

    Report Number
    2518436-2009-00001
    Event Type
    Death
    Date Received
    September 1, 2009
    Date of Event
    June 21, 2008
    Report Date
    August 31, 2009
    Manufacturer
    INSTRUMENTATION INDUSTRIES, INC.
    Product Code
    BTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUMENTATION INDUSTRIES APOLOGIZES FOR THE LATENESS IN SUBMITTING THIS REPORT. DUE TO THE LENGTH OF TIME THAT ELAPSED BETWEEN THE DEATH OF VICTIM IMMEDIATELY FOLLOWING THE 2008 TRAFFIC ACCIDENT, AND THE DATE OF WHEN THE COMPANY WAS SERVED WITH LEGAL PAPERS, THE COMPANY DID NOT IMMEDIATELY RECOGNIZED THE NEED TO FILE THE MDR. THIS REPORT IS BEING FILED DESPITE THE SCARCITY OF INFORMATION ABOUT THE ACTUAL USAGE OF OUR DEVICE AT THE ACCIDENT SCENE, IN ORDER TO COMPLY WITH FDA REGULATIONS. THE LEGAL STAFF EMPLOYED BY INSTRUMENTATION INDUSTRIES BELIEVES THAT THIS IS A NUISANCE LAWSUIT. THE COMPANY WILL UPDATE THE FDA WHEN ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    INSTRUMENTATION INDUSTRIES INC BECAME AWARE OF THE PT'S DEATH ON 7/10/2009 WHEN SERVED WITH NOTICE THAT THE COMPANY WAS BEING SUED. WHILE A PASSENGER IN AN AUTOMOBILE, THE PATIENT SUFFERED MULTIPLE TRAUMATIC INJURIES IN A HEAD-ON COLLISION WITH ANOTHER AUTOMOBILE IN 2008. EMERGENCY MEDICAL STAFF ADMINISTERED TREATMENT AT THE SCENE OF THE ACCIDENT. THE PATIENT DIED AT THE SCENE. THE LAWSUIT CLAIMS THE PATIENT DIED "FROM MULTIPLE TRAUMATIC INJURIES, GROSSLY NEGLIGENT CARE AND TREATMENT BY THE EMERGENCY MEDICAL STAFF AND DEFECTIVE INSTRUMENTATION INDUSTRIES, INC EQUIPMENT USED AT THE SCENE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BE 183-XXX (EXACT MODEL NUMBER IS UNKNOWN) MANUAL JET VENTILATOR BTL INSTRUMENTATION INDUSTRIES, INC. BE 183-XXX NI

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Death