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

Model Number	10430603
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2024
Type of Reportable Event	Malfunction
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.The instructions for use provide instructions to the user to prevent such an event.See excerpt below.According to the instructions for use (definition flash / instructions for use); print no.Hc-c2-030.621.19.01.02, page 412 ff., chapter 6.4.3 preparing the patient - warning box: incorrect patient positioning! injury to the patient by moving parts.¿ make sure that neither the patient¿s clothing nor hair can get caught in mechanical parts.¿ make sure that infusion lines and respiration tubes, catheters and ecg cables cannot get caught in the space between the table top and the side parts.These components must not be put under tensile stress in any other way.¿ make sure that patient bedding cannot get caught by moving parts of the patient table.¿ use positioning aids as described.According to the instructions for use (definition flash / instructions for use); print no.Hc-c2-030.621.19.01.02, page 412 ff., chapter 6.4.4 moving the patient to the scan start position - 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 table top 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 a malfunction occurred while operating the somatom definition flash ct system.On (b)(6), 2024, while scanning a patient, the customer had excess blankets on the table at the head end.When bringing the patient out of the gantry, the blankets slipped from the patient handling system (phs) and onto the plexi ring.The moving table then pushed the stacked sheets into the plexi ring.The blankets became caught in the rotating part of the gantry, pulling the ecg monitor into the plexi ring and ultimately breaking it.The patient was safely removed from the system and there is no report of impact to the state of health of any patient or user involved.Therefore, this report has been submitted with an abundance of caution.

• Brand Name: SOMATOM DEFINITION FLASH
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1 ~or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemensstrasse 1 ~or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 18815736
• Report Number: 3004977335-2024-00026
• Device Sequence Number: 17228931
• Product Code: JAK
• UDI-Device Identifier: 04056869006963
• UDI-Public: 04056869006963
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K230421
• 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
• Type of Report: Initial
• Report Date (Section B): 03/01/2024

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: 10430603
• Device Catalogue Number: 10430603
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2024
• Initial Report FDA Received Date: 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown