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

Model Number	10431700
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	02/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported event.As this event is under investigation, a root cause has not yet been definitively determined.A supplement report will be filed upon completion of the investigation.
Event or Problem Description
Siemens became aware of a malfunction the occurred while operating the somatom drive ct system.On (b)(6) 2024, during a patient scan the monitor ceiling system (mcs) holder axis slipped a few centimeters out of the tube shaft.The mcs did not completely detach from the ceiling, however, the operator, who was located under the system, was hit.The operator reported a sore shoulder as a result of this incident.Siemen was not provided a report of impact to the state of health of the patient involved and if medical treatment was necessary.
Additional Manufacturer Narrative
B5: additional information was received by siemens healthineers regarding the health status of the operator.H3, h6: the investigation is ongoing.A root cause has not yet been identified.A supplemental report will be submitted to the fda upon completion of the investigation.
Event or Problem Description
Additional information: siemens healthineers received additional information regarding the health status of the involved operator.The operator went to the physiotherapist for a check-up, and their shoulder was fine.No medical intervention was required.
Additional Manufacturer Narrative
Siemens has completed an investigation of the event.Our technical investigation revealed that a countersunk screw was not installed properly during installation.When the supporting arm was moved to the set end positions with momentum and force, as it was confirmed by the affected customer, the cup screw became loose so much that it fell out, causing the supporting arm to lower by a few centimeters and hit the operator's shoulder.An analysis of our complaint data showed that there are no other occurrences with marketed devices having the same issue.Siemens has improved the installation instructions and put an additional installation flyer into the sealing arm packages.This action has immediate effect for all ex-factory devices.

• Brand Name: SOMATOM DRIVE
• 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 libeerty blvd. 65-1a; malvern, PA 19355 ; 4843231631
• MDR Report Key: 18864269
• Report Number: 3004977335-2024-00029
• Device Sequence Number: 16970778
• Product Code: JAK
• UDI-Device Identifier: 04056869006970
• UDI-Public: 04056869006970
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/20/2024

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: 10431700
• 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: 02/21/2024
• Supplement Date Received by Manufacturer: 06/28/2024; 08/08/2024
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 07/01/2024; 08/22/2024
• 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