MAUDE Adverse Event Report: SIEMENS HEALTHINEERS AG SOMATOM EMOTION 16; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number	07734713
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the somatom emotion 16 ct system.The customer reported that the head holder on the patient table detached during a patient positioning procedure.There was no impact to the state of health of the patient involved.
Additional Manufacturer Narrative
Siemens has completed an investigation of the event.A safety assessment has been performed, and no general product or design issue could be identified.The reported problem was corrected with repair of the head holder.The system was returned to clinical operation, and no further investigation is necessary.

• Brand Name: SOMATOM EMOTION 16
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHINEERS AG; siemensstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHINEERS AG; siemensstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 22715189
• Report Number: 3004977335-2025-00094
• Device Sequence Number: 9207010
• Product Code: JAK
• UDI-Device Identifier: 04056869013114
• UDI-Public: (01)04056869013114
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K050297
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 07734713
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Male