MAUDE Adverse Event Report: GE HEALTHCARE (TIANJIN) COMPANY LIMITED 1.5T SIGNA ARTIST 96; NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number	SIGNA ARTIST
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D: there are no additional device identification numbers.G2: (b)(6).H3, 6: ge healthcare's investigation is ongoing.A follow up report will be submitted once the investigation has been completed.
Event or Problem Description
It was reported that a patient felt "intense and strong heat" on their right side during a mr examination of the right shoulder.There is no report of a burn or other typical sign of significant rf-related injury.This event was initially assessed as not reportable as warming during an mr exam may occur due to the rf energy, and typically results in minor discomfort which is self-resolving.Subsequently, the ge healthcare complaint handling unit became aware of additional information from the patient that describes ongoing pain that requires pain medication; therefore, we have updated our assessment to a serious injury.The cause or source of the ongoing pain has not been clearly identified.Based on the service and preventative maintenance records that we have reviewed for the system from the time of the event until now, we do not have any evidence that the system malfunctioned, however our investigation is ongoing.
Additional Manufacturer Narrative
B4; g1, 3, 6; h2, 3, 6.H3: ge healthcare (gehc) has concluded its investigation.A review of system service records confirms that the mr system was operating within specifications, with no identified issues or defects.Based on the available information, no apparent root cause for the patient injury has been determined.Rf warming can occur due to the coupling with high-power radiofrequency transmissions of an mr scanner during normal clinical use, even while operating within specifications.The operator manual includes warnings about tissue heating, even when good clinical practices and proper rf padding are followed.Gehc does not plan any further actions at this time.

• Brand Name: 1.5T SIGNA ARTIST 96
• Common Device Name: NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GE HEALTHCARE (TIANJIN) COMPANY LIMITED; no.266 jingsan road; tianjin airport economic area; tianjin 30030 8; CH 300308
• Manufacturer (Section G): GE HEALTHCARE (TIANJIN) COMPANY LIMITED; no.266 jingsan road; tianjin airport economic area; tianjin 30030 8; CH 300308
• Manufacturer Contact: andy koch ; 3200 n. grandview blvd.; waukesha, WI 53188
• MDR Report Key: 20643359
• Report Number: 3010949642-2024-00006
• Device Sequence Number: 7464501
• Product Code: LNH
• UDI-Device Identifier: 00840682123129
• UDI-Public: (01)00840682123129(11)170727
• Combination Product (Y/N): N
• Initial Reporter Country: LU
• PMA/510(K) Number: K163331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2025

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
• Operator of Device: Health Professional
• Device Model Number: SIGNA ARTIST
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 60 KG