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

Model Number 11330001

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 12/11/2023

Event Type  Injury  

Manufacturer Narrative

D3: manufacturer¿s email address is (b)(4).E1: the reporting facility telephone number is (b)(6).H3, h6: siemens healthineers is conducting a thorough investigation of the reported event.The investigation is ongoing.A supplemental report will be filed upon completion of the investigation and only if a systematic or design issue is identified as the root cause of this event and/or if additional reportable information regarding the patient¿s health status is received.

Event Description

It was reported to siemens healthineers on december 13, 2023, by the customer that on december 11, 2023, an injury occurred during a ct examination with a somatom x.Cite ct scanner in france.The left-hand finger of a 77-years-old patient got caught in the gap between the moving table-top and table, resulting in injury to the finger.The patient was treated medically by suturing the injured finger with a few stitches.As of the date of this report, no further information has been received regarding the patient's health status, extent of injury, and medical treatment; therefore, this report is being conservatively submitted as a potential serious injury.Additional information has been requested and is pending receipt by siemens healthineers.

• Brand Name: SOMATOM X.CITE
• Type of Device: 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: rebecca tudor ; 40 liberty blvd., mc 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 18371978
• MDR Text Key: 331182259
• Report Number: 3004977335-2023-00165
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 04056869231044
• UDI-Public: 04056869231044
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K211373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11330001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 77 YR
• Patient Sex: Female