MAUDE Adverse Event Report: TOSHIBA MEDICAL SYSTEMS CORPORATION X08A; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)

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

Event Date 07/11/2017

Event Type  malfunction  

Event Description

Mri scanner screen was frozen while scanning a patient.Mri technologist had to shut scanner down numerous times during am shift.Mri dept got 2+ hrs behind schedule, engineer was notified and told us to shut scanner down for 30 minutes.Two patients were re-scheduled for a later date.

• Brand Name: X08A
• 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: 7013633
• MDR Text Key: 91468397
• Report Number: 7013633
• 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: 11/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Other Device ID Number: MFXL1504
• Was Device Available for Evaluation?: Yes
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1