MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH MAGNETOM AERA; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number 10432914

Device Problem Use of Device Problem (1670)

Patient Problems Bone Fracture(s) (1870); Patient Problem/Medical Problem (2688)

Event Date 11/06/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Siemens is conducting a thorough investigation of the reported events.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed upon completion of the investigation.

Event Description

An obese patient was positioned with the left and right arms along the body with a head coil.It is assumed that the positioning of the patient was head first supine, however, no clear statement regarding the patient positioning could be identified.After the examination was completed, the patient table was moved out of the magnet system.The patients right arm was pinched between the table and the magnet bore during table movements.The patient suffered a compression fracture causing a humeral head fracture on the upper arm.Due to body paralysis of the right half of the patient's body, the squeeze ball was placed in the left hand, however, the patient did not press the squeeze ball and alert the operator at the time of the injury.The patient was provided medical treatment immediately and the fracture is healing without the need for surgery.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.Assessment of the reported incident does not indicate a system failure or malfunction and no non-conformity was identified.The root cause was determined to be user error.The system was evaluated by a siemens service engineer and found to be operating within specification.No hardware problem was found which would explain the reported fracture on the patient's right upper arm.The root cause for the fracture is a direct skin-to-cover contact of the left arm to the magnet bore wall.This represents an inadequate or incorrect positioning as described in the magnetom operator manual (mr-02501g.621.01.02.02 - page 20/21).In order to avoid such incidents in the future, it is advised to always follow the instructions given in the operator manual regarding correct patient positioning.Always position the patient so that the patient's arms are aligned with the torso and ensure that hands, arms, and legs do not touch (minimum distance: 5 mm).Ensure that the minimum distance of 5 mm is maintained between patient and tunnel covering to ensure this distance, use positioning aids, e.G.Blankets made of linen, cotton, or paper, or dry material that is permeable to air.The manufacturer is not considering further actions resulting from this event as no systematic error has been recognized.

• Brand Name: MAGNETOM AERA
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkestrasse 127; erlangen, germany 91052 ; GM 91052
• MDR Report Key: 8482565
• MDR Text Key: 140905959
• Report Number: 3002808157-2018-56184
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K173592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10432914
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/21/2018
• Event Location: Hospital
• Date Report to Manufacturer: 12/21/2018
• Date Manufacturer Received: 03/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 150