MAUDE Adverse Event Report: SIEMENS AG / SIEMENS HEALTHCARE GMBH MAGNETOM SYMPHONY TIM

Device Problem Compatibility Problem (2960)

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

Event Date 04/20/2018

Event Type  No Answer Provided  

Event Description

Pt was not placed on mri compatible stretcher, so pt and ed bed entered mri scan room and were attracted to the scanner.

• Brand Name: MAGNETOM SYMPHONY TIM
• Type of Device: MAGNETOM SYMPHONY TIM
• Manufacturer (Section D): SIEMENS AG / SIEMENS HEALTHCARE GMBH
• MDR Report Key: 7534289
• MDR Text Key: 109104460
• Report Number: MW5077394
• 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: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 116