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

Model Number INFX-8000V

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 02/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(6) regional hospital reported that the patient moved while technicians were monitoring her.Then patient rolled to her side and fell from the table.The technician just barely caught her before she hit the floor.As a result, the patient fractured her elbow.According to the operation manual " before performing a study, tell the patient not to move unless otherwise instructed.Also, pay attention to patient movement during the actual study to ensure that the patient does not move.".It has been determined by the manufacturer that the cause of the incident is human error by the operator.

Event Description

A patient rolled off table and fractured elbow.

• Brand Name: CANON
• Type of Device: FLUOROSCOPIC X-RAY 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: paul biggins ; 2441 michelle drive; tustin, CA 92780 ; 7147305000
• MDR Report Key: 7317404
• MDR Text Key: 101662255
• Report Number: 2020563-2018-00001
• 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: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 02/28/2018

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: Medical Technologist
• Device Model Number: INFX-8000V
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/05/2018
• Initial Date FDA Received: 03/06/2018
• Date Device Manufactured: 12/01/2009
• 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
• Patient Outcome(s): Other