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

Model Number	8098027
Medical Device Problem Codes	Mechanical Problem (1384); Unintended Collision (1429)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Siemens healthineers has become aware of a potential risk for patient health when using the somatom definition as ct system.No such event has occurred at this time.During service actions it was recognized that the phs (patient handling system - patient table) and the gantry of the scanner may collide if the table is in the highest possible position and the gantry is tilted in a positive direction by up to +30 degrees.If a patient would be on the table, potential harm cannot be excluded.Siemens is investigating to determine the root cause for this behavior.
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported events.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed upon completion of the investigation.
Additional Manufacturer Narrative
Siemens has completed an investigation of the event.During the technical investigation, it was determined that all collision tables were working as specified.For this combination of patient handling system (phs) and ct system, the positive tilt angle is defined as +30 degrees.Accessories such as the head holder used are not considered in collision tables.The reported situation was observed during service activities where the phs was driven into the maximum height position.During regular patient examination the table is positioned in a vertical position to be in iso-center of the gantry and not in the highest table position.Table movements and gantry tilting are performed by trained operators only.Also, for tilting of the gantry, the operator has to be directly next to the patient and has to hold the button for moving the gantry at all times.This is always a controlled movement, and it stops immediately if the button is released.Therefore, an accidental injury can be excluded as patients must always be observed during system movement.Assessment of complaints from the past three years does not show any injury as alleged in the described situation.A possible error accumulation or even a systematic error, which would lead to a corrective action of the installed base, could not be determined by the investigation.

• Brand Name: SOMATOM DEFINITION AS
• 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; siemensstr. 1; rittigfeld 1; forchheim, germany 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 16223346
• Report Number: 3004977335-2023-59880
• Device Sequence Number: 5350375
• Product Code: JAK
• UDI-Device Identifier: 04056869003665
• UDI-Public: 04056869003665
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2023

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: 8098027
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2023
• Supplement Date Received by Manufacturer: 02/23/2023
• Initial Report FDA Received Date: 01/23/2023
• Supplement Report FDA Received Date: 02/23/2023
• 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
• Patient Sex: Unknown