MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH-CT 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 05/06/2022

Event Type  Injury  

Event Description

It was reported to siemens that an adverse event occurred while operating the somatom drive ct system.It was reported that a confused patient underwent a ct examination of the abdomen.The examination was conducted in which the patient was moved twice through the device without any problems.After asking the radiologist, the patient was allowed to leave the table.When the patient table was driving out of the device, the patient unexpectedly folded her knee so that it could no longer pass through the device.The knee became stuck and the plexi glass of the ct scanner broke.As a result, the patient suffered an injury to the left knee.Furthermore, it was reported that the patient was not fixated as recommended in the instruction for use.The emergency physician evaluated the patient and she was transferred to the emergency department for further follow-up.The patient suffered partial tissue loss approximately 6cm x 4.5cm in diameter up to the patella.The lesion is clear with no signs of infection and the wound environment is intact.The patient is currently under the care of a physician and further treatment has not yet been determined.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.Assessment does not indicate a system failure or malfunction and no non-conformity was identified.The patient was not fixated as recommended in the instruction for use.

• Brand Name: SOMATOM DRIVE
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH-CT; siemensstr. 1; forchheim, germany 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH-CT; siemensstr. 1; forchheim, germany 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 14573240
• MDR Text Key: 293163503
• Report Number: 3004977335-2022-27121
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 04056869006970
• UDI-Public: 04056869006970
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2022
• 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: 05/20/2022
• 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): Required Intervention
• Patient Sex: Female