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

Model Number 11344916

Device Problem Use of Device Problem (1670)

Patient Problems Unspecified Musculoskeletal problem (4535); Unspecified Tissue Injury (4559)

Event Date 07/16/2023

Event Type  Injury  

Manufacturer Narrative

B1, b2, b5, h1: the customer did not provide siemens with enough information regarding the event or nature and extent of the report of "injury".Siemens is conservatively reporting this event as a serious injury, although additional information from the customer is still pending receipt by siemens as of the date of this report.H3, h6: as of the date of this report, the details of the event are unclear, and it is not known whether or not the reported device will be made available for investigation.The codes entered in section h3 are based on a worst-case scenario only, with the assumption the iv pole became stuck to the mr magnet due to use error.A supplemental report will be submitted upon receipt of additional event and device information.

Event Description

The customer initially reported that an iv pole became stuck to the mr magnet.In response to an email from siemens requesting additional information regarding the event and potential injury, the customer responded by email on (b)(6), 2023, stating "yes" in response to the question "did an injury occur?".The customer stated they would not disclose additional information regarding the nature and severity of the injury, need for medical intervention, current health status of the injured person, or additional event details, and that siemens should contact the risk manager.Although additional attempts have been made by siemens to obtain this information from the risk manager, a response has not been received by siemens as of the date of this report.Due to the unknown nature and severity of the injury, siemens decided to perform an "in doubt" reporting of this event.

Manufacturer Narrative

B5: additional event information was provided by the user facility risk manager and added.H3, h6: siemens healthineers has completed the investigation of the reported event.It was initially communicated that on july 16, 2023, an iv pole stuck in the magnet.No information about a possible injury was provided at the time of the initial report.Upon request by siemens healthineers for additional information the local siemens customer service engineer (cse) reported back on july 21, 2023 that the customer only provided the information that an injury occurred.However, the customer did not provide any details regarding the seriousness of the injury or any possible medical treatment.The cse was referred to the hospital risk manager.The risk manager informed us that a response from their legal team would require three to six months.We contacted the hospital¿s current risk manager after this said period and received detailed information about the incident.The risk manager informed siemens healthineers that two technicians were injured when the magnetic iv pole was attracted by the magnet.One technician was struck in the head, but the injury was very minor and did not require medical treatment.The other technician was struck in the hand, and the injury required surgical treatment.Siemens was informed that both technicians have fully recovered and back to work.Additionally, it was stated by the risk manager, that one technician was an mri tech, and the other was a staff technician (not mri).The hospital has implemented additional measures to prevent another occurrence of ferromagnetic material being attracted by the magnet.Siemens healthineers assessed the complained event and concluded that the cause of this event was the introduction of ferromagnetic pieces into the mr examination room and therefore an individual user error.Due to the strong magnetic field, special safety measures have to be adhered to in order to prevent injuries.Therefore, the corresponding magnetom operator manual and the magnetom system owner manual provide clear instructions and warnings regarding both magnetic field hazards and training of personnel with regards to mr safety.However, the responsibility to instruct personnel and patients who have access to the mr examination room about magnetic field hazards lies with the customer.The manuals state that only equipment specified or recommended for use in the controlled area (mr examination room) shall be used.The introduction of ferromagnetic objects into the magnetic field is contrary to the statements given in the operating instructions.Furthermore, the required warning sign is placed at the entrance door (magnet room) as required by the operator manual.To ensure distance, use positioning aids, e.G., blankets made of linen, cotton, or paper, or dry material that is permeable to air.This complaint has been closed with no additional measures.H6: codes were updated based on additional information received from facility risk manager.

Event Description

The risk manager informed siemens healthineers that two technicians were injured when the magnetic iv pole was attracted by the magnet.One technician was struck in the head, but the injury was very minor and did not require medical treatment.The other technician was struck in the hand, and the injury required surgical treatment.Siemens was informed that both technicians have fully recovered and back to work.Additionally, it was stated by the risk manager, that one technician was an mri tech, and the other was a staff technician (not mri).The hospital has implemented additional measures to prevent another occurrence of ferromagnetic material being attracted by the magnet.

• Brand Name: MAGNETOM LUMINA
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkestrasse 127; erlangen 91052 ; GM 91052
• Manufacturer (Section G): SIEMENS HEALTHINEERS AG; allee am röthelheimpark 2; erlangen 91052 ; GM 91052
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd., mc 65-1a; malvern, PA 19335 ; 4843234198
• MDR Report Key: 17546159
• MDR Text Key: 321175145
• Report Number: 3002808157-2023-00009
• Device Sequence Number: 1
• Product Code: LNH
• UDI-Device Identifier: 04056869230740
• UDI-Public: 04056869230740
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220939
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 05/08/2024

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?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/21/2023
• Initial Date FDA Received: 08/14/2023
• Supplement Dates Manufacturer Received: 05/07/2024
• Supplement Dates FDA Received: 05/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other