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

Model Number 10432915

Device Problem Positioning Problem (3009)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 04/17/2023

Event Type  Injury  

Manufacturer Narrative

E1: a facility contact name was not provided for reporting purposes.H10: the siemens healthineers customer service engineer (cse) visited the site and replaced both right-side wheels, the 5th wheel, and the bowden cables.The cse confirmed the proper functioning of the dockable patient table, and demonstrated the functioning of the 5th wheel.However, the customer continued to have the same issue with the dockable patient table during movement.The 5th wheel is the guiding wheel allows for better directional stability and easier steering.Depending on the position of the lateral pedal on the lower long side of the dockable patient table, the guiding wheel is deactivated, activated or the table brakes are engaged.During the on-site visit the cse noticed that the 5th wheel was not engaged.The investigation is ongoing.A supplemental report will be submitted if additional information is obtained upon the completion of the investigation.

Event Description

It was reported to siemens healthineers that on (b)(6) 2023, the dockable patient table was drifting to the right during movement.It was stated that a technologist from the hospital hurt their shoulder trying the resist against the pulling of the dockable patient table, without specifying the severity of the injury.Siemens healthineers requested additional information regarding the nature and extent of the technologist injury, but additional information was not received at that time and the complaint was initially deemed not reportable.Per the additional information received by siemens healthineers on (b)(6) 2023, it was stated that the customer was not very forthcoming regarding the injury to the technologist.It was clarified that injured technologist will not be able to return to work immediately.However, siemens healthineers was not given any information regarding a diagnosis, the severity of the injury or medical intervention.Siemens healthineers is thus reporting this incident due to the technologist's injury, since based on the available information, was severe enough to prevent the technologist from working.

Manufacturer Narrative

H3, h6: siemens healthcare completed the investigation of the reported issue.Siemens became aware that there may have been a serious injury associated with this issue which occurred with a magnetom skyra system.Per the complaint information from 2023-04-17 it was stated that the dockable patient table was drifting to the right during movement.It was further stated that a technologist from the hospital hurt their shoulder trying to fight against the pulling of the dockable patient table.The severity of the injury was not specified.Per the additional information from 2023-05-03 it was clarified that the injured person was not able to return to work immediately.However, siemens was not given any additional information regarding a diagnosis, the severity of the injury, or possible medical intervention.The patient table is equipped with a guiding wheel (5th wheel) which allows for better directional stability and easier steering.The 5th wheel can be engaged and disengaged by the user via an adjustable pedal.Depending on the position of the pedal the 5th wheel is disengaged (lifted) or engaged (lowered).In the third pedal position the break is engaged.The magentom family - operator manual - mr system, syngo mr e11 provides a detailed description of how to handle the patient table when it is intended to be moved.For turning the table in place, navigating in curves, and moving the table straight ahead the operator manual instructs the user to set the lateral pedal to the middle position to lower/activate the guiding wheel.In the initial information provided by the customer to siemens healthineers customer service, the customer stated that the problem with the 5th wheel would intermittently occur when transitioning from the brake to the 5th wheel.There have been five (5) on-site service deployments of siemens healthineers customer service engineers (cses) regarding the steering issue.In addition, the customer was attended to by our customer service via telephone.During the 4th on-site visit the lead technologist from the hospital informed our cse about the injury.The results of the cses investigation during the 5 visits can be summarized as follows: -the issue could barely be reproduced by the customer or the cses during their on-site visits.Sometimes it was impossible to reproduce the problem with the 5th wheel at all.Other times it took the cses up to 30 attempts to reproduce the issue.Preventatively some components of the patient table have been replaced or rerouted.-after each service the 5th wheel was tested with the customer, and the guiding wheel was performing properly.It was explained to the customer, that the patient table should not be used with a patient on it if the 5th wheel is not engaged properly.-siemens informed the customer that in every case when the 5th wheel engages late, to move the patient table left to right to engage the 5th wheel.-it was also found, that in areas where customer was experiencing the most issues with the patient table drifting, the floor was not in a good condition or not levelled.At the docking station the flooring was cracked and expressed large bumps elevating the floor.Between the examination room and the patient loading area the passage is narrow.In the hallway, the tiles/flooring was very damage due to construction in this area.Our experts identified the problem for the reduced directional stability to likely be the 5th wheel not being properly engaged.However, since in this case the wheels were replaced and adjusted several times as a preventive measure by the service department, we have ruled out a technical error as the cause for the drifting of the patient table.During the development of the patient table the usability of moving the patient table was tested.No difficulties while moving the patient table were found during the test sessions.Additionally, it was noted that the table is always undocked and placed outside the room when not in use.During the 4th on-site visit, the cse made the customer aware that the fifth wheel was not engaged.We therefore conclude that the customer is not moving the patient table correctly since for a stable patient table movement the 5th wheel would have to be engaged.Finally, it was stated by the customer that this issue has been resolved in the meantime.The medical staff was retrained on how to use the 5th wheel.The injured staff member participated in this training and confirmed that the patient table no longer drifts.

• Brand Name: MAGNETOM SKYRA
• 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: 16930269
• MDR Text Key: 315199305
• Report Number: 3002808157-2023-71003
• Device Sequence Number: 1
• Product Code: LNH
• UDI-Device Identifier: 04056869006703
• UDI-Public: 04056869006703
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10432915
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other