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

Model Number 8098027

Device Problem Use of Device Problem (1670)

Patient Problem Laceration(s) (1946)

Event Date 04/26/2022

Event Type  Injury  

Manufacturer Narrative

Siemens has initiated an investigation of the reported event.The system user manual was reviewed with the customer showing all relevant safety information.The patient was not fixated on the patient table as recommended in the user manual.Although no device malfunction was reported, siemens requested the gap dimensions between the moving and stationary portions of the table to ensure the dimensions are within specification.As of the date of this report, siemens has not received the request measurements.Siemens considers the root cause of this event as a user error.Siemens will provide a supplemental report to the fda if additional information indicating a device malfunction is received.

Event Description

It was reported to siemens that the patient sustained a hand injury during the ct examination.The (b)(6) patient could not raise her arms above her head and had grabbed on to the patient table while it was extended into the gantry.When the patient table was moved out of the gantry, the patient did not let go of the table and the skin of four fingers was lacerated.The patient's fingers were not broken.The scan had been successfully completed but the patient was transported to another facility of the hospital for hand surgery.The patient is now recovering from the event.Additional information was not provided to siemens.The reporting facility did not allege that the ct scanner malfunctioned.

• Brand Name: SOMATOM DEFINITION AS
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 14494877
• MDR Text Key: 292576080
• Report Number: 3004977335-2022-25976
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 04056869003665
• UDI-Public: 04056869003665
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8098027
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/27/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 89 YR
• Patient Sex: Female