BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CINEMAVISION A/V SYSTEM

    MDR report key: 2682630 · Received July 20, 2012

    Report

    Report Number
    2029299-2012-00001
    Event Type
    Injury
    Date Received
    July 20, 2012
    Date of Event
    April 17, 2012
    Report Date
    July 20, 2012
    Manufacturer
    RESONANCE TECHNOLOGY, INC.
    Product Code
    LNH
    PMA / PMN Number
    K994351
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS SUBMITTED AS A RESULT OF NEW INFO THAT WAS RECEIVED BY RESONANCE TECHNOLOGY, INC ON (B)(4) 2012, (REFERENCE REPORT (B)(4) FORWARDED TO FDA). THIS COMPLAINT ALLEGES THAT IMMEDIATE AND FOLLOW UP MEDICAL CARE WAS REQUIRED. THIS CONTRADICTS INFO PROVIDED BY THE USER FACILITY (THE CHILDREN'S HOSPITAL DENVER) WHO ORIGINALLY REPORTED THIS COMPLAINT TO RESONANCE TECHNOLOGY, INC IN 2008, AND STATED THAT THERE WAS NO PT INJURY. CHILDREN'S HOSPITAL DENVER WAS NOT WILLING TO RETURN THE DEVICE TO RESONANCE TECHNOLOGY INC FOR EVALUATION. HOWEVER, ON (B)(4) 2009, WAS ALLOWED TO EVALUATE. (B)(6) WAS ABLE TO EVALUATE THE DEVICE ON-SITE AT THE HOSPITAL. HIS VISUAL INSPECTION CONFIRMED THAT THE VISOR EXHIBITED SIGNS OF DAMAGE/WEAR. IT WAS MISSING THE PROTECTIVE LENS AND THE GROUNDING WAS FRAYED. NEW INFO IN REPORT (B)(4) STATES THAT THE DEVICE WAS REPAIRED BY THE HOSPITAL BIOMEDICAL DEPARTMENT PRIOR TO THE ADVERSE EVENT. RESONANCE TECHNOLOGY INC'S CINEMAVISION USER MANUAL (REV 0 - THIS WAS THE CURRENT VERSION IN 2008), PAGE 3 STATES "ONLY AUTHORIZED RESONANCE TECHNOLOGY PERSONNEL SHOULD PERFORM ALL REQUIRED SERVICE ON THIS SYSTEM. FAILURE TO COMPLY WITH THIS WARNING MAY RESULT IN PROPERTY DAMAGE OR INJURY OR DEATH FROM ELECTRIC SHOCK, FIRE, OR OTHER CAUSE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CINEMAVISION A/V SYSTEM LNH RESONANCE TECHNOLOGY, INC. RTC-551-000-000-000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention