MAUDE Adverse Event Report: TOSHIBA MEDICAL SYSTEMS CORPORATION TITAN; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number MKSU-ECGU04

Device Problems Unintended Magnet Quench (1377); Device Displays Incorrect Message (2591)

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

Event Date 08/28/2017

Event Type  malfunction  

Event Description

When checked into work this morning, error on monitor for mri system stated helium warning, below 30%.I opened up scan room door, tested magnet to see if there was a magnetic field, and there was not.Service was immediately called, and service engineer came in.He stated he believed it was an "unattended quench".Service engineer stated we will be down for 5 days.More than 50 patients are affected by the system being down.All patients for entire week have to be cancelled/rescheduled.

• Brand Name: TITAN
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): TOSHIBA MEDICAL SYSTEMS CORPORATION; paul biggins; 2441 michelle drive; tustin CA 92780
• MDR Report Key: 7009341
• MDR Text Key: 91358909
• Report Number: 7009341
• Device Sequence Number: 1
• Product Code: LNH
• 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: Patient
• Type of Report: Initial
• Report Date: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MKSU-ECGU04
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2017
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 09/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1