MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH- MR MAGNETOM AVANTO FIT; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number 10849579

Device Problem Use of Device Problem (1670)

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

Event Date 01/09/2020

Event Type  Injury  

Manufacturer Narrative

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

It was reported to siemens that an adverse event occurred while operating the magnetom avanto fit system.The user reported that a patient fractured three ribs during a breast examination when raising the arms.No further details were provided regarding the procedure.The patient was taken to the emergency room for evaluation and the fractured ribs were confirmed.It is not known what medical treatment was provided.Siemens has requested additional information in order to conduct an investigation of the reported event.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The root cause was determined to be a user error.Our experts investigated the complained issue.According to the received information, the operator used the "center position button" to move the patient into the bore for a breast examination.Due to a claustrophobic attack, the patient pressed the squeeze ball to alert the operator, but the operator did not stop the table (e.G.By pressing the e-stop).While the table was moving into the bore, the patient became wedged inside the bore when forcing the table to stop resulting in a fracture of 3 ribs.The operator manual for the "sentinelle" breast coil mr-04011g.623.24.02.02 clearly states that special attention must be paid with respect to patient handling: - chapter 4.1.5: the operator has to carefully pay attention to the patient while moving the patient manually into the magnet bore.The customer shall not use the "center position button".That means the operator is required to manually move the patient into the magnet bore and to ensure that the patient get not injured during patient table movements.- in addition, chapter 2.2.1 emphasizes that operator has to take care to use the correct riser for the corresponding coil to avoid injuries of the patient.In addition, the operator manual mr-02501g.621.01.02.02 provides further general information with respect to patient positioning to avoid formation of electric current loops: e.G.- the minimum distance of 5 mm between patient and tunnel covering has to be ensured (to ensure the distance positioning aids are available).- the patient should always positioned that the patient´s arms are aligned with the torso and ensure that the hands, arms, and legs do not touch (minimum distance 5 mm) the system is equipped with a squeeze ball and an intercom for the patient to alert the operator in the event of experiencing discomfort.Pressing the squeeze ball does not stop table movements.To avoid issues like this in the future, we recommend the following: - train staff that that only the jog wheel or the move buttons should be used during breast examination with breast coils (do not use the "center position button", or move via remote from the mr console).- customer has to take care for the patients during table movement / examination and in case of discomfort / emergency stop the examination.No information was received which reasonable suggests that a malfunction of the device contributed to the injury of the customer.Therefore, we consider this issue as an user error / training issue.

• Brand Name: MAGNETOM AVANTO FIT
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH- MR; henkestrasse 127; erlangen, germany 91052 ; GM 91052
• MDR Report Key: 9601185
• MDR Text Key: 177537644
• Report Number: 3002808157-2020-14977
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K190757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10849579
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other