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

Model Number MDX-8000A

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

Patient Problems Fall (1848); Head Injury (1879); Spinal Column Injury (2081)

Event Date 08/24/2011

Event Type  Injury  

Manufacturer Narrative

Patient was placed on table for exam with head at foot end of table.The table suddenly began to move to the upright position.Operator allegedly did not perform any system operation.The table was immediately returned to the horizontal position.The problem did not reoccur and the system could be operated normally thereafter.There were no error log entries on the system corresponding to this event.It was confirmed that all system functions were normal and no abnormalities in the parts related to the tilt switch.It was determined that there were no abnormalities in the system, and therefore the only possible cause was unintended operation of the tilt switch.

Event Description

Patient was placed on table for exam with head at foot end of table.The table suddenly began to move to the upright position.Operator allegedly did not perform any system operation.The patient fell to the floor and was injured on the head and spine.

• Brand Name: TOSHIBA
• Type of Device: FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): TOSHIBA MEDICAL SYSTEMS CORPORATION; 1385 shimoishigami; otawara-shi, tochigi 324-8 550; JA 324-8550
• Manufacturer (Section G): TOSHIBA 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: 5279462
• MDR Text Key: 33158351
• Report Number: 2020563-2015-00007
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/26/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MDX-8000A
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 95 YR