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

Model Number INFX-8000

Device Problem Insufficient Information (3190)

Patient Problem Sprain (2083)

Event Date 05/31/2017

Event Type  Injury  

Manufacturer Narrative

It was reported by the customer that the tech was moving the c-arm using the buttons on the back of the c-arm.She intended to move it laterally but instead the c-arm traveled longitudinally towards the foot end of the table.It was additionally reported that this caused the tech to become caught between the c-arm and a mobile cart causing a slight sprain to her wrist.An investigation of the c-arm and its wiring were conducted by the manufacturer.No problems were found; the switch operated normally.The switch wiring was replaced by third party service.The c-arm travel speed was also investigated.It can be noted that the c-arm may seem to be traveling faster to an operator due to its design.The tech allegedly stated that the c-arm continued to move without the buttons being pressed.The driving buttons are located on the back of the c-arm.Without pressing, the buttons will not activate the power of the motor.Once pressure is released from the button, the motor will stop immediately.However, the c-arm is unable to stop immediately due to inertial force.There is a slow down time which is a specification of the device.The manufacturer has determined that the cause of the problem is user error because of misunderstanding in regard to slow down time.Please note that at normal speed, the distance to stop completely os about 7 cm.Customer submitted report to fda - (b)(4).

Event Description

Slight wrist sprain.

• Brand Name: TOSHIBA
• Type of Device: FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): TOSHIBA MEDICAL SYSTEMS CORPORATION; 1385 shimoishigami; otawara-shi, 324-8 550; JA 324-8550
• Manufacturer (Section G): TOSHIBA MEDICAL SYSTEMS CORPORATION; 1385 shimoishigami; otawara-shi, 324-8 550; JA 324-8550
• Manufacturer Contact: paul biggins ; 2441 michelle drive; tustin, CA 92780 ; 7147305000
• MDR Report Key: 6802403
• MDR Text Key: 82982396
• Report Number: 2020563-2017-00008
• 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,user f
• Reporter Occupation: Service Personnel
• Type of Report: Initial
• Report Date: 07/20/2017

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: Radiologic Technologist
• Device Model Number: INFX-8000
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/02/2017
• Initial Date FDA Received: 08/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other