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

Model Number 11344916

Device Problem Insufficient Information (3190)

Patient Problem Limb Fracture (4518)

Event Date 05/23/2022

Event Type  Injury  

Manufacturer Narrative

Customer contact name was not provided to siemens.Siemens has initiated a technical evaluation of the reported event.A supplemental report will be submitted if additional information is obtained or upon completion of the investigation.

Event Description

It was reported to siemens that after the mr examination, the patient's left arm was broken during horizonal table movement.The patient was immediately admitted by the emergency team.It was confirmed that the left humerus was broken.The patient is now at home.Siemens has not received any information from the customer as to whether the fracture had to be treated conservatively (immobilization by a plaster cast, splint, support bandage) or surgically treated.This report has been submitted with an abundance of caution.The reported event occurred in (b)(6).

Event Description

Additional event information: additional information was provided by the customer facility during the investigation of the event.The patient was described as being very large in stature and that there was nothing next to the system table during the incident.The patient was dressed in a tank top during the examination.Her mobility was described as limited.The patient was positioned dorsally decubitus and the arms placed next to the body but not fixed with straps.A head coil was used.Anonymized patient images were not provided to siemens.The customer did not answer siemens' inquiry regarding why the patient did not acuate the squeeze bulb to alert the technician during the incident.The customer facility stated that after finishing the examination, the patient was informed by an operator about the move out of the patient table.The operator activated the home button outside the examination room while maintaining visual contact.The patient table moved out of the bore and the patient screamed.The patient table had come to a stop halfway.Another operator went to the patient and noticed that the left arm got stuck on the inner wall of the mri (suction cup effect).He then lifted the table to take the pressure off the patients arm and then took the arm off the wall.Then he pulled out the table so that the patient could be taken off the table.

Manufacturer Narrative

A: patient height is 175cm.B5: additional event information obtained during the investigation of the reported event.H3, h6, h10: siemens completed the investigation of the reported event.The initial complaint involved a female patient (age: 69, weight: 102 kg) who broke her arm during the horizontal movement of the table after an examination with an magnetom lumina system.A siemens service technician evaluated the reported system, and it was found to be within specification.Siemens experts retrieved the event logs recorded at the time of the examination on may 23, 2022.The position of the tabletop indicates that the patient presumably underwent a head examination.The tabletop was moved to the isocenter position at 12:53:03.Shortly thereafter, the examination room was closed, and the measurement started.At 13:09:06 the tabletop began to be moved out of the bore.After a movement of about 37 cm (after about 4 seconds), a "horizontal movement error" occurred.About 9 seconds later, the door to the examination room was opened and after another 3 seconds, the rotary wheel on the control panel was turned, allowing the operator to initially move the tabletop back by about 30 cm.2 seconds later, the operator moved the table top out again by 29 cm and immediately back inwards by 43 cm.After another 10 seconds, the complete exit of the tabletop into the starting position began, which was triggered by the operator.Based on the available information, the incident was re-investigated by siemens experts.They have tried to simulate the described situation on one of our test systems.A person of the similar size to the patient was placed on the patient table for a head examination and moved in the magnet to the appropriate position for a head examination.It was found that the person's forearms were still in front of the magnetic opening.Only the elbows were in the front funnel.A touch of the arms on the inner wall could not be detected.In addition, an attempt was made to recreate why the patient table stopped by itself with a "horizontal movement error".The automatic stop of the patient table was triggered by a drag error (runtime error).This means that the tabletop has been stopped by an obstacle.Based on the position data from the event log, the tabletop moved outward for 4 seconds before the patient table came to a stop due to the drag error.In this position, the patient is already outside the magnet up to the head.Therefore, based on the patient's position after the tabletop was automatically stopped and the tabletop position data from the event log, it is unclear why the operator moved the tabletop back into the magnet after resetting the error message.In the examination procedure described by the customer, it was stated that the operator immediately moves the table upwards to relieve the arm.For patient safety, it is not possible to move the patient table vertically while the tabletop is in the bore.The exact root cause for the left humeral fracture cannot be identified.The system operator manual (operator manual - mr system and coils, syngo mr xa31, print no.Mr-02601g.621.07.02.02) contains the following safety instructions: - chapter 2 - safety, point 2.2.3, page 25 - 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).- chapter 2 - safety, point 2.2.5, page 30 secure the patient's arms and legs with straps so that the patient is not caught between the tabletop and the magnet cover.Remain in the mr examination room with helpless patients (e.G., children and patients who are either seriously ill, paralyzed, unconscious, sedated, handicapped, or medicated), even if the patients are secured during the examination.- chapter 3 - intercom, point 3.8.1, page 85 patients, for example, sedated patients, who may not be able to alert the personnel must be monitored by a person present in the examination room.- chapter 5 - mr system operation, point 5.5.1, page 129 show the patient how to activate the patient alert by pressing the squeeze bulb.Ensure that the patient holds the squeeze bulb in his/her hand during the measurement.In compliance with the above measures, it is not known how this incident could have occurred.As previously stated, a root cause could not be determined.H11: a4: patient weight is 102 kg.Internal id# (b)(4).

• Brand Name: MAGNETOM LUMINA
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH - MR; henkestrasse 127; erlangen, 91052 ; GM 91052
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH - MR; henkestrasse 127; erlangen, 91052 ; GM 91052
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 14642166
• MDR Text Key: 294839266
• Report Number: 3002808157-2022-29590
• Device Sequence Number: 1
• Product Code: LNH
• UDI-Device Identifier: 04056869230740
• UDI-Public: 04056869230740
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K220939
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11344916
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/03/2022
• Initial Date FDA Received: 06/09/2022
• Supplement Dates Manufacturer Received: 11/03/2022
• Supplement Dates FDA Received: 11/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 102 KG