MAUDE Adverse Event Report: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 830 TANDEM; SYSTEM,TOMOGRAPHY,COMPUTED,EMISSION

Model Number	NMH972
Medical Device Problem Code	Misassembled During Installation (4049)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Udi number: (b)(4).Legal manufacturer: hcs haifa fi - 4 hayozma st.Israel tirat hacarmel hefa, 30200.Ge healthcare's investigation is ongoing.A follow up report will be submitted when the investigation has been completed.
Event or Problem Description
A ge healthcare field engineer sustained a finger fracture during the installation of an 830 tandem system detector.The injury occurred when the engineer left index finger became trapped between the gantry swivel mechanism and the detector while moving the detector toward the swivel mechanism.
Additional Manufacturer Narrative
During detector installation, the fe was pushing the detector cart toward the gantry swivel mechanism and had positioned the detector approximately 50% of the way onto the guiding rods when he encountered some resistance.He left a 5 cm gap between the detector and the swivel, repositioned himself, and then applied additional force to the detector cart using his left hand.This force caused the detector cart to move rapidly, during which the tip of the fes left index finger came in between the mating parts, resulting in a fracture.The fe secured the detector in place and then sought first aid.Later that day, he returned and completed the installation.Ge healthcare's investigation determined that the root cause was inattentiveness by the fe while following the installation procedure.The risk analysis determined that no additional mitigations are available to reduce the risk, and the risk has been reduced as far as possible.No further actions are planned by ge healthcare.

• Brand Name: 830 TANDEM
• Common Device Name: SYSTEM,TOMOGRAPHY,COMPUTED,EMISSION
• Manufacturer (Section D): GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING; 4 hayozma st.; tirat hacarmel 30200 ; IS 30200
• Manufacturer (Section G): GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING; 4 hayozma st.; tirat hacarmel 30200 ; IS 30200
• Manufacturer Contact: ofer simhoni ; functional imaging; 4 hayozma st.; tirat hacarmel 30200 ; IS 30200
• MDR Report Key: 23769969
• Report Number: 9613299-2025-00027
• Device Sequence Number: 21268005
• Product Code: KPS
• UDI-Device Identifier: 00840682140829
• UDI-Public: (01)00840682140829(11)250910
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K111445
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2026

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: NMH972
• 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: 11/13/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2025
• 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: Required Intervention; Other
• Patient Sex: Male