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

Model Number 10431700

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Laceration(s) (1946)

Event Date 03/18/2022

Event Type  Injury  

Event Description

It was reported to siemens that after completion of the ct examination, the patient pushed his knee into the system scan window (plexi ring) as the hospital staff were trying to restrain him.The event resulted in a moderate injury to the patient.The patient sustained a 3.5 cm laceration to the anterior portion of his knee.The wound was treated and closed with three (3) sutures and three (3) staples.Aside from this injury, no other negative health consequences were reported to siemens.There was no allegation of device malfunction.The patient was not fixated properly before the procedure as recommended in the system user manual.This report has been submitted with an abundance of caution.

Manufacturer Narrative

Siemens has completed the investigation of the reported event.There was no allegation of device malfunction.The patient was not fixated properly before the procedure as recommended in the system user manual.

• Brand Name: SOMATOM DRIVE
• 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: 13995898
• MDR Text Key: 288495978
• Report Number: 3004977335-2022-20919
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 04056869006970
• UDI-Public: 04056869006970
• 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: 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10431700
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/19/2022
• 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: 37 YR
• Patient Sex: Male
• Patient Weight: 73 KG