MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH MAGNETOM TRIO, A TIM SYSTEM; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number 10018221

Device Problem Use of Device Problem (1670)

Patient Problems Bone Fracture(s) (1870); Laceration(s) (1946); Physical Entrapment (2327)

Event Date 11/28/2018

Event Type  Injury  

Event Description

Patient was undergoing an mri under sedation.The patient was placed under general anesthesia.She was wrapped with sheets and towels with both hands tucked inside the sheet.While the tech was pushing the button to move the patient forward, headfirst into the scanner, he felt resistance.The tech saw that the patient's left ring finger was caught between the table and the scanner.Further assessment revealed a laceration, torn tendon and chipped bone.Gap between the table and the scanner.

• Brand Name: MAGNETOM TRIO, A TIM SYSTEM
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; 40 liberty boulevard; mailcode: 65-1a; malvern PA 19355
• MDR Report Key: 8343408
• MDR Text Key: 136273081
• Report Number: 8343408
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/07/2019

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: 10018221
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/07/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/15/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 27740 DA