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

Model Number 1045617750

Device Problem Device Handling Problem (3265)

Patient Problem Abrasion (1689)

Event Date 08/16/2022

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 300123383
• Report Number: 3004977335-2022-40734
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 04056869006970
• UDI-Public: 04056869006970
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K190578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 1045617750
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/31/2022
• Initial Date FDA Received: 09/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Sex: Female