BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOSHIBA

    MDR report key: 1084725 · Received July 24, 2008

    Report

    Report Number
    2020563-2008-00002
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    April 23, 2008
    Report Date
    July 8, 2008
    Manufacturer
    TOSHIBA MEDICAL SYSTEM CORP
    Product Code
    IZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FLUOROSCOPIC PERFORMANCE EVALUATION WAS CONDUCTED BY A PHYSICIST PER THE ADMINISTRATIVE CODE (TAC) REGULATIONS AS WELL AS ADDITIONAL IMAGE QUALITY STANDARDS (E.G., RADIATION SAFETY, IMAGE QUALITY, ETC.) THE SYSTEM WAS EVALUATED IN 2008, AND AGAIN THREE MONTHS LATER, JUST AFTER THIS INCIDENT WAS REPORTED. THERE WERE NO PROBLEMS NOTED AND THE SYSTEM PASSED ALL REQUIREMENTS. ERROR LOG DATA AND STUDY INFORMATION FROM THE DATA BASE HAVE BEEN OBTAINED FROM SITE FOR INVESTIGATION INTO THE CAUSE OF THIS INCIDENT. A REVIEW OF THIS INFORMATION DID NOT REVEAL A SYSTEM PROBLEM, BUT DID REVEAL THAT THE STUDY EXPOSURE TIME WAS APPROXIMATELY 160 MINUTES AS REPORTED. TOSHIBA DOES NOT BELIEVE FURTHER ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IN 2008, IT WAS REPORTED THAT A PATIENT ALLEGEDLY EXPERIENCED A RADIATION BURN. IT WAS FOUND THAT THE PATIENT WAS EXPOSED FOR APPROXIMATELY 160 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOSHIBA X-RAY, DIGITAL FLUOROGRAPHY IZG TOSHIBA MEDICAL SYSTEM CORP DFP-8000D

    Patients

    Seq Age Sex Outcome Treatment
    1 Other