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

Model Number	1045617750
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	08/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to siemens that an adverse event occurred while operating the somatom drive ct system.A 66 year old female patient was examined on (b)(6) 2022.The patients finger was stuck between the table mattress and the free space resulting in a soft tissue deformation and open wound with scratches.It is reported that the patient's finger is in good condition and no medical intervention was required.Therefore, this report has been submitted with an abundance of caution.
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.The root cause was determined to be a handling issue.A safety assessment was performed.No general product issue could be identified based on available information and the investigation of the table showed that all gaps and dimensions are within specification.According to the instructions for use (drive | instructions for use; print no.C2-047.621.06.02.02, chapter 2.3.1 patient table, page 63) caution boxes: horizontal tabletop movement! possible injury to the hand (warning label).Do not place your hand in the gap of the tabletop support.Lowering the patient table! body parts can get caught.Make sure that the patient's body parts are above the patient table.Make sure that neither body parts of anybody nor any objects are below the patient table.

• 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: 15445241
• Report Number: 3004977335-2022-40734
• Device Sequence Number: 18024896
• Product Code: JAK
• UDI-Device Identifier: 04056869006970
• UDI-Public: 04056869006970
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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): 09/19/2022

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: 1045617750
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2022
• Initial Report FDA Received Date: 09/19/2022
• 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: Other
• Patient Age: 66 YR
• Patient Sex: Female