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

Model Number DFP-8000D

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fall (1848)

Event Date 12/14/2016

Event Type  Injury  

Manufacturer Narrative

The procedure was a generator replacement for a pacemaker.The hospital personnel and physician were operating system from patient left of table and the c-arm was on patient right of table.The hospital personnel stated that the patient was restrained using bilateral wrist restraints tied to the iv rails with slip knots.The case was completed and the physician was closing the entry point with sutures.According to the hospital personnel, the physician pulled the last suture and the patient rolled off the table toward the physician and fell to the floor.The patient was then taken for an mri to determine if there were any injuries.The table pad in use at the time of the procedure was an aftermarket pad (not purchased from (b)(6)) and was larger than the table top of the system.We have been unable to obtain any additional information from the hospital on the status of the patient.

Event Description

A patient fell off table during generator replacement procedure for a pacemaker.

• 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: 6268697
• MDR Text Key: 65457848
• Report Number: 2020563-2017-00001
• 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,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/19/2017

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: Health Professional
• Device Model Number: DFP-8000D
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2016
• Initial Date FDA Received: 01/20/2017
• Date Device Manufactured: 02/01/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 134