MAUDE Adverse Event Report: SIEMENS AG / SIEMENS HEALTHCARE GMBH SIEMENS MRI; SYSTEM, NUCLEAR, MAGNETIC RESONANCE IMAGING

Model Number 7391167

Device Problem Electromagnetic Interference (1194)

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

Event Date 08/01/2019

Event Type  Injury  

Event Description

Ferrous non-mri safe rolling iv pole was brought into mri room and was immediately pulled into magnet.There was no injury to pt or staff.Magnet was powered down via controlled process by field serviceman retaining helium level.Unit was returned to full service august 2, 2019.

• Brand Name: SIEMENS MRI
• Type of Device: SYSTEM, NUCLEAR, MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS AG / SIEMENS HEALTHCARE GMBH
• MDR Report Key: 8922677
• MDR Text Key: 155341612
• Report Number: MW5089239
• 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: 08/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 7391167
• 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