MAUDE Adverse Event Report: CANON MEDICAL SYSTEMS CORPORATION CANON; INFINIX VC-I FD VASCULAR SYSTEM

Model Number INFX-8000C/UD

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Information (3190)

Event Date 10/22/2018

Event Type  malfunction  

Manufacturer Narrative

A touch sensor detects a contact when a load exceeds a certain threshold.It is considered that the touch sensor did not detect a contact because the contact force was lower than its threshold.This is the device specification.The following measures are implemented and performed so that touch sensors works as intended: the system has a function that detects failure for touch sensors.It has a fail-safe design and is configured to detect faults.So, when the fail-safe function operates, a system error will generate.Detector movements are slowed down around a patient by an interference prevention function.Touch sensors are inspected to work correctly when they are shipped, and once again once they are installed at the site.Customers need to perform pre-operational checks when they start a study everyday.This is noted in the operation manual.The following contents described in the operation manual will be explained once again to the customer: pre-operational check to confirm that touch sensors work safely and as intended.To be mindul that the touch sensor may push against a patient.We judge that no further action beyond what is specified in this summary is needed.[medwatch report mw5081940].

Event Description

From the original medwatch report submitted by the facility: "female patient had been found to have had 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.She then went for a stat arterial embolization.During an interventional radiology procedure, the fpd sensor in the interventional suite lowered down and touched the patient's abdomen.Normally, upon touching the patient, the fpd sensor raises up and prevents itself from touching the patient.This day, the sensor did not work and the sensor stayed against the patient, causing her some pain.The fpd sensor was immediately lifted off of the patient by the radiology technician standing next to her.The third party maintenance company was called, and the fpd sensor was replaced".Please note that the customer mistakenly noted the fpd sensor as the image intensifier.This has been corrected in the above report for accuracy.

• Brand Name: CANON
• Type of Device: INFINIX VC-I FD VASCULAR SYSTEM
• Manufacturer (Section D): CANON MEDICAL SYSTEMS CORPORATION; 1385 shimoishigami; otawara-shi, tochigi, 324-8 550; JA 324-8550
• Manufacturer (Section G): CANON MEDICAL SYSTEMS CORPORATION; 1385 shimoishigami; otawara-shi, tochigi, 324-8 550; JA 324-8550
• Manufacturer Contact: 2441 michelle drive; tustin, CA 92780
• MDR Report Key: 8414464
• MDR Text Key: 139819804
• Report Number: 2020563-2019-00001
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: user facility
• Reporter Occupation: Nurse
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 12/04/2018,03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: INFX-8000C/UD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/04/2018
• Distributor Facility Aware Date: 12/27/2018
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/28/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1