MAUDE Adverse Event Report: TOSHIBA MEDICAL SYSTEMS CORPORATION UNKNOWN; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

Model Number DP18/1216CS

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2017

Event Type  malfunction  

Event Description

When physician stepped on fluoroscopy pedal, system came up with a software system error, and then the system rebooted.This is not the first time this has occurred.Called into toshiba and reported.No harm to patient.

• Brand Name: UNKNOWN
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• Manufacturer (Section D): TOSHIBA MEDICAL SYSTEMS CORPORATION; paul biggins; 2441 michelle dr.; tustin CA 92780
• MDR Report Key: 7159774
• MDR Text Key: 96235846
• Report Number: 7159774
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: DP18/1216CS
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/13/2017
• Event Location: Hospital
• Date Report to Manufacturer: 12/13/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR