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

Device Problems Electrical /Electronic Property Problem (1198); Device Inoperable (1663); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/14/2016

Event Type  malfunction  

Event Description

This morning we turned on the live x-ray toshiba machine, and we did our normal q/a that we perform every morning.We were not able to fluoro or cine.It said "power supply error" on the monitors.This was considered equipment failure: the toshiba cath lab system not functioning.Toshiba was called in to repair.We needed to cancel several cases on thursday and friday.We cancelled inpatient cvicu and nicu patients and outpatient for the shutdown period.The family for the thursday case traveled from (b)(6) and was staying in a hospital waiting until monday to perform the procedure.Cath lab repair took 3 days to complete: thursday, friday, and saturday.Toshiba has been present the following monday and wednesday to ensure equipment is functioning properly.The manager for toshiba has called in assistance from international headquarters to follow up on the continued concerns with the cath lab equipment since toshiba upgrade in august 2015.

• Brand Name: UNKNOWN
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• Manufacturer (Section D): TOSHIBA AMERICA MEDICAL SYSTEMS, INC.; paul biggins; 2441 michelle dr.; tustin CA 92780
• MDR Report Key: 6054047
• MDR Text Key: 58295968
• Report Number: 6054047
• 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: 06/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/17/2016
• Event Location: Hospital
• Date Report to Manufacturer: 06/17/2016
• 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