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

Model Number 10590000

Device Problem Unintended Collision (1429)

Patient Problem Fracture, Arm (2351)

Event Date 01/02/2020

Event Type  Injury  

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The investigation did not reveal a malfunction of the ct system, but a deeper investigation was not possible due to missing log files.Based on the investigation and interview with the facility, it is unknown if the ct collision resulted in the patient's arm fracture or not.No further action is warranted at this time.

Event Description

It was reported to siemens that during a ct scan with the somatom definition edge system the ct gantry collided with the unconscious patient.The patient's arms were taped above the head during the scan and it is unknown if the collision resulted in an arm fracture or if the patient's arm was fractured prior to the scan.This event has been filed with an abundance of caution.

• Brand Name: SOMATOM DEFINITION EDGE
• 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 ; 6104486484
• MDR Report Key: 9641462
• MDR Text Key: 177149642
• Report Number: 3004977335-2020-13936
• Device Sequence Number: 1
• Product Code: JAK
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10590000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/02/2020
• 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