MAUDE Adverse Event Report: SIEMENS AG / SIEMENS HEALTHCARE GMBH / SIEMENS MEDICAL SOLUTIONS USA, INC. MRI ; SYSTEM, NEUCLEAR MAGNETIC RESONANCE IMAGING

Model Number SYMPHONY

Device Problems Device-Device Incompatibility (2919); Unintended Movement (3026)

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

Event Date 05/25/2019

Event Type  No Answer Provided  

Event Description

Non-mr compatible iv pole brought into mr room in error and flew into mr unit while patient was on the mr table.

• Brand Name: MRI
• Type of Device: SYSTEM, NEUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS AG / SIEMENS HEALTHCARE GMBH / SIEMENS MEDICAL SOLUTIONS USA, INC. ; erlangen ; GM
• MDR Report Key: 8865123
• MDR Text Key: 153675671
• Report Number: MW5088786
• 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: Physician
• Type of Report: Initial
• Report Date: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SYMPHONY
• Was Device Available for Evaluation?: No
• 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: 57 YR
• Patient Weight: 68