MAUDE Adverse Event Report: GE HEALTHCARE (TIANJIN) COMPANY LIMITED; NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number	SIGNA CREATOR
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	01/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D: there are no additional device identification numbers.H3, 6: ge healthcare's investigation is ongoing.A follow up report will be submitted once the investigation has been completed.Legal manufacturer: (b)(6).
Event or Problem Description
During servicing of a gehc mr system, a service contractor brought a ferrous crimping tool into the magnet room when it was pulled from their hand by the magnet.It is reported the service contractor sustained a dislocated finger and laceration to the right palm that was sutured.
Additional Manufacturer Narrative
H3: ge healthcare (gehc) has concluded its investigation into the incident involving a ferrous crimping tool brought into a scan room by a third-party contractor while supporting gehc field service engineers (fes) during a servicing event.Magnets inherently attract ferrous objects, and the magnet functioned within specification when it attracted the ferrous tool.The root cause was identified as user error of inattentive personnel.The signa creator/explorer service manual gradient coil replacement procedure, and the mr systems service safety manual, both provide adequate instructions and warnings for handling gradient crimping and cutting tools in the magnet room, and service personnel are responsible for following the gehc safety procedures.The existing mitigations which include warning signs on the scan room door, site protective measures (e.G., controlled/locked access), user and service safety manual instructions and patient pre-screening instructions are in place and effective.No further actions are planned by gehc.

• Brand Name: NA
• 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: 21458705
• Report Number: 3010949642-2025-00002
• Device Sequence Number: 7913575
• Product Code: LNH
• UDI-Device Identifier: 00840682113786
• UDI-Public: (01)00840682113786(11)190716
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K143251
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2025

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 CREATOR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2025
• Supplement Date Received by Manufacturer: 03/21/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2019
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 43 YR
• Patient Sex: Male