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

Model Number 8098027

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Bone Fracture(s) (1870); Laceration(s) (1946)

Event Date 09/22/2021

Event Type  Injury  

Manufacturer Narrative

Siemens completed the technical investigation of the reported event.The investigation confirmed the patient table gap dimensions were within tolerance.Neither a device malfunction, nor a general design issue have been identified.The root cause of the issue is user error.Per the associated system user manual, it is recommended, that the arm support should be used (user doc print no.Hc-c2-029.621.07.01.02, page 221).Further investigation within the complaint process is not deemed necessary.

Event Description

It was reported to siemens that a (b)(6) year-old female patient suffered abrasions and fractures to the 3rd, 4th and 5th phalanges of her left hand during a ct examination using the somatom definition as system.During table movement, the patient grabbed the system tabletop which resulted in her hand being caught between the tabletop and the table's stationary frame.The patient was positioned feet first prone on the ct table and the fixation straps were not used.The technologist confirmed a safe hand position before leaving the ct room.The patient received medical treatment for her injuries at the mercy health emergency department.Additional information regarding the event and the patient's health condition were not provided to siemens.

• 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
• MDR Report Key: 12616684
• MDR Text Key: 275972252
• Report Number: 3004977335-2021-98485
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 04056869003665
• UDI-Public: 04056869003665
• Combination Product (y/n): N
• PMA/PMN Number: K190578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 10/11/2021

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: 8098027
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/24/2021
• Initial Date FDA Received: 10/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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: 82 YR
• Patient Weight: 83