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

Model Number 10431700

Device Problems Entrapment of Device (1212); Material Separation (1562); Noise, Audible (3273)

Patient Problem Laceration(s) (1946)

Event Date 08/12/2020

Event Type  Injury  

Event Description

On (b)(6) 2020 - a tier 3 trauma patient came into the siemens drive ct scanner for an exam of the head, cervical spine, chest, abdomen and pelvis.Prior to coming to ct, the patient had an altered status and was given a sedative to help ease the patient during the ct scan.Once the ct was completed, and the technologist used the console controls home button to begin to bring the patient out of the gantry.As the technologist opened the door, the patient began screaming and load noises started coming from the ct scanner.The patient had pressed against the "tube cover mylar ring" which then was caught internally by one of the components inside the gantry.As the ring rotated through the gantry, pieces of it ripped and launched throughout the room, lacerating the patient's right arm and knee - requiring stitches.The technologists pressed the emergency button on the scanner near the ipad and removed the patient from the table completely.The concern is that the patient while pressing on the tube cover/mylar ring occurred, it so easily became dislodged within the gantry.Fda safety report id# (b)(4).

• Brand Name: SIEMENS SOMATOM DRIVE
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS
• MDR Report Key: 10431071
• MDR Text Key: 203835569
• Report Number: MW5096149
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10431700
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 98