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

Device Problems Device Operates Differently Than Expected (2913); Unintended Movement (3026)

Patient Problem Injury (2348)

Event Date 05/31/2017

Event Type  malfunction  

Event Description

While attempting to position the c-arm to the opposite side of the patient, the buttons controlling movement of the c-arm malfunctioned (toshiba single plane c-arm continued to move fast without buttons being pressed) and caused employee to get pinned between c-arm and supply cabinet, which caused an injury to the employee.

• Brand Name: INFINIX
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): TOSHIBA MEDICAL SYSTEMS CORPORATION; 2441 michelle dr.; tustin CA 92780
• MDR Report Key: 6701300
• MDR Text Key: 79632485
• Report Number: 6701300
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/05/2017

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: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/05/2017
• Event Location: Hospital
• Date Report to Manufacturer: 06/05/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/11/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other