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

Model Number 10684332

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 10/12/2020

Event Type  Injury  

Event Description

With patient sitting upright on mr table, the table was lowered into the trolley, the patient fingers were in that gap between table and trolley, and were pitched (injured.) when the table is lowered onto the trolley, they come in close proximity to one another, with risk of crush injury / damage to anything that may be in the closing gap.Fda safety report id# (b)(4).

• Brand Name: MAGNETOM AVANTO DOT
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS AG/SIEMENS HEALTHCARE GMBH
• MDR Report Key: 11214194
• MDR Text Key: 228430874
• Report Number: MW5098943
• Device Sequence Number: 1
• Product Code: LNH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10684332
• 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 Outcome(s): Required Intervention