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

Model Number	10431700
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	09/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.The root cause was determined to be a handling error.The patient should be fixed according to the instructions for use (print no.(b)(4), page 65, chapter 2.3 safety information on patient transport and positioning).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.Caution box: incorrect patient positioning! injury to the patient or personnel, and damage to the equipment.Always verify that the patient is correctly positioned.Always observe the patient during system movements.
Event or Problem Description
It was reported to siemens that an adverse event occurred while operating the somatom drive ct system.It was reported that a patient broke through the ct gantry plexi-ring (scan window) with his knee during an examination on (b)(6) 2022.The hospital did not use any straps to prevent the patient from moving as the patient was in a great amount of pain.During the scan, the patient experienced distress and kicked his knee into the plexi-ring, breaking through the plexi-ring and meeting the rotating part of the gantry.The patient was immediately sent to the emergency department for evaluation and received stitches in the knee before being sent home.We are unaware of any furhter impact to the state of health of the patient involved.There was no device malfunction reported.Therefore, this report has been submitted with an abundance of caution.

• Brand Name: SOMATOM DRIVE
• 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: 15474579
• Report Number: 3004977335-2022-44856
• Device Sequence Number: 19950480
• Product Code: JAK
• UDI-Device Identifier: 04056869006970
• UDI-Public: 04056869006970
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K190578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 09/22/2022

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: 10431700
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 09/23/2022
• 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: Required Intervention
• Patient Sex: Unknown