MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC; TOMOGRAPHICIMAGERCOMBININGEMISSION

Model Number	SIGNA PET MR
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Limb Pain (4836)
Date of Event	03/17/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Legal manufacturer: hcs mr - 3200 n grandview blvd.Usa waukesha, wi 53188.D2 common device name: tomographic imager combining emission computed tomography with nuclear magnetic resonance.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.
Event or Problem Description
After completion of an exam, a technologist tripped over tubing from the patient alert ball that had extended onto the scan room floor while the patient was removed from the bore of the scanner.The technologist fell, landing on the right knee, striking the nose, and injuring the left shoulder while attempting to brace the fall.The technologist sought medical evaluation at an urgent care facility the following day and was diagnosed with a left chest contusion and left shoulder strain, with subsequent initiation of physical therapy.No patient injury occurred.

• Brand Name: NA
• Common Device Name: TOMOGRAPHICIMAGERCOMBININGEMISSION
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3200 n grandview blvd.; waukesha, WI 53188
• Manufacturer (Section G): GE MEDICAL SYSTEMS, LLC; 3200 n grandview blvd.; waukesha, WI 53188
• Manufacturer Contact: andy koch ; 3200 n. grandview blvd.; waukesha, WI 53188
• MDR Report Key: 24884715
• Report Number: 2183553-2026-00002
• Device Sequence Number: 18604692
• Product Code: OUO
• UDI-Device Identifier: 00840682105378
• UDI-Public: (01)00840682105378(11)210503
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K163619
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2026

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 PET MR
• 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: 03/26/2026
• Supplement Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 04/15/2026
• Supplement Report FDA Received Date: 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2021
• 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: 49 YR
• Patient Sex: Female
• Patient Weight: 63 KG