BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOSHIBA-CANON INFINIX- 1

    MDR report key: 8142323 · Received December 6, 2018

    Report

    Report Number
    MW5081940
    Event Type
    Injury
    Date Received
    December 6, 2018
    Date of Event
    October 22, 2018
    Report Date
    December 4, 2018
    Manufacturer
    TOSHIBA-CANON MEDICAL SYSTEMS USA, INC.
    Product Code
    JAA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS IS A (B)(6) FEMALE WHO HAS A KNOWN HISTORY OF (B)(6). SHE HAS UNDERGONE (B)(6) TREATMENT. SHE HAS BEEN FOLLOWED AND FOUND TO HAVE AN ENLARGING LESION IN THE RIGHT POSTEROLATERAL PORTION OF THE RIGHT LOBE OF THE LIVER. THIS LESION UNDERWENT BIOPSY. ON STANDING THE PATIENT UP, SHE BECAME ORTHOSTATIC AND TACHYCARDIC AND THERE WAS CONCERN ABOUT POST BIOPSY BLEEDING. THE PATIENT WENT FOR A STAT CTA WHERE THERE WAS SEEN TO BE SOME EXTRAVASATION AND SHE THEN WENT FOR A STAT ARTERIAL EMBOLIZATION. DURING AN INTERVENTIONAL RADIOLOGY PROCEDURE, THE IMAGE INTENSIFIER IN THE INTERVENTIONAL SUITE LOWERED DOWN AND TOUCHED THE PATIENT¿S ABDOMEN. NORMALLY, UPON TOUCHING THE PATIENT, THE DEVICE THEN HAS A SENSOR THAT FUNCTIONS AND HAS THE IMAGE INTENSIFIER RAISE UP FROM TOUCHING THE PATIENT. THIS DAY, THE SENSOR DID NOT WORK AND THE IMAGE INTENSIFIER STAYED AGAINST THE PATIENT CAUSING HER SOME PAIN. THE IMAGE INTENSIFIER WAS IMMEDIATELY LIFTED OFF THE PATIENT BY THE RADIOLOGY TECH STANDING NEXT TO HER. THE MAINTENANCE COMPANY WAS CALLED AND THE PART WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979347 TOSHIBA-CANON INFINIX- 1 INTERNATIONAL FLUOROSCOPIC X-RAY SYSTEM JAA TOSHIBA-CANON MEDICAL SYSTEMS USA, INC. DETECTOR SOFT COVER

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR