MAUDE Adverse Event Report: CANON MEDICAL SYSTEMS CORPORATION CANON; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number INFX-8000C/UC

Device Problem Use of Device Problem (1670)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/15/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturer determined that this incident is attributed to an operator handling issue.According to the warning in the system operation manual (2b302-124en*d): "before performing a study, tell the patient not to move unless otherwise instructed.Also, pay attention to patient movement during the study to ensure that the patient does not move".The customer has requested that canon medical systems usa (cmsu) offer a recommendation on which straps, available for order, would be best used to mitigate the associated risk.Cmsu is reaching out to the customer to address this request.The customer stated that, in the meantime, they are using velcro to secure patients.No corrective action is planned, as this was determined by the manufacturer to be caused by user error.For preventive action, canon plans to suggest a proposal to this customer to tie up patients using standard accessories for this catheterization table.

Event Description

Customer alleged that an interventional radiology patient positioned prone slipped laterally and fell from table to floor during conclusion of procedure.Caregivers were next to table at the time of the incident, but customer noted that patient fell on his own.Patient was described as heavily sedated during the scan.Patient was centered and mattress stayed in place.Patient received serial ct scans afterwards.Customer alleged that small subarachnoid hemorrhage was found in patient during ct scans.Customer determined that no surgery was necessary.Customer noted that after the event, the patient was in the icu for co-morbidities.There is no evidence at this time linking the hemorrhage to any co-morbidities.Patient was placed on a table cushion manufactured by burlington medical, which customer described as "non-slip".Table cushion was purchased directly by the customer, and not by canon medical.

• Brand Name: CANON
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): CANON MEDICAL SYSTEMS CORPORATION; 1385 shimoishigami; otawara-shi, tochigi 324-8 550; JA 324-8550
• MDR Report Key: 11881612
• MDR Text Key: 252647135
• Report Number: 2020563-2021-00001
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial
• Report Date: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: INFX-8000C/UC
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/06/2021
• Initial Date FDA Received: 05/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR