MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH-CT SOMATOM X.CITE; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number	11330001
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	10/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.Assessment does not indicate a system failure or malfunction and no non-conformity was identified.Based on the information available, no general product problem could be identified and the investigation of the table showed that all gap dimensions are within specification.The instructions for use was reviewed and deemed to adequately provide instructions to the user to prevent such an event.See excerpt below.According to the instructions for use (somatom x.Cite i instructions for use; print no.C2-060a-g.621.03.02.02, page 30 ff., chapter 2.4.8 moving the patient table or gantry) warning box: incorrect patient positioning, unintended patient movement, and unobserved movement of the patient table or gantry! injury to the patient, for example, contusions of the patient's extremities and unusable radiation.Always fix the patient with accessories, as described in the instructions for use, to avoid unintentional patient movement.For example, use restraint straps and arm supports.Monitor the patient continuously as long as the tabletop and gantry are moving.Take special care if the tilt of the gantry is anything other than zero degrees or the table height is anything other than the isocenter.Make sure that nothing can get caught while the table or gantry are moving.For example, parts of the body or clothing, any needles, infusion tubes, respiration tubes, catheters, ecg cables, or sheets and blankets.Follow the markings and labels on the equipment.Press a stop key if an injury to the patient can occur.
Event or Problem Description
It was reported to siemens that an adverse event occurred while operating the somatom x.Cite ct system.It was reported that a patient's (70 years old, male) arm was trapped in the patient table on (b)(6),2022.According to the customer, the patient was lying head first and face down.After the scan, when the table moved out, the skin of the patient's arm was pinched between the table and the table top.An approximately 4-5 cm hematoma formed, which was treated with hydrosalve.No other injuries were reported.Therefore, this report has been submitted with an abundance of caution.

• Brand Name: SOMATOM X.CITE
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH-CT; siemensstr. 1 -or-; rittigfeld 1; forchheim, germany 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH-CT; siemensstr. 1 -or-; rittigfeld 1; forchheim, germany 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 15959755
• Report Number: 3004977335-2022-53446
• Device Sequence Number: 14840333
• Product Code: JAK
• UDI-Device Identifier: 04056869231044
• UDI-Public: 04056869231044
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K211373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 12/12/2022

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: 11330001
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2022
• Initial Report FDA Received Date: 12/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR
• Patient Sex: Male