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

Model Number	10431700
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	08/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Siemens has completed a technical investigation of the reported complaint.The root cause is attributed to the external forces from the patient on the plexi-ring and gantry cover which resulted in these components breaking.The patient's arms were not fixated, and the patient would not listen to the ct technician's instructions to stop moving.The broken components were replaced by a siemens customer service engineer.No device malfunction was identified.A supplemental report will be submitted if additional reportable information becomes available.
Event or Problem Description
It was reported to siemens that after completion of a ct scan, the customer was moving the patient out of the gantry and the patient reacted by pushing against the plexi-ring and gantry cover.Due to the external force, the ct plexi-ring and gantry cover broke.The patient subsequently sustained lacerations to the hand and knee as a result.The patient was taken back to the emergency department of the facility for medical treatment of the injuries; however, no additional information was provided to siemens.According to the operator, before the ct scan, the patient was initially admitted to the emergency department.The reason for admission is unknown.During the ct examination, the patient's arms were not fixated, and the patient would not listen to the ct technician's instructions to stop moving.

• Brand Name: SOMATOM DRIVE
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 10475942
• Report Number: 3004977335-2020-42104
• Device Sequence Number: 3001529
• Product Code: JAK
• UDI-Device Identifier: 04056869006970
• UDI-Public: 04056869006970
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K190578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/31/2020

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: 08/12/2020
• Initial Report FDA Received Date: 09/01/2020
• 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