SIEMENS AERA MRI UNIT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-06 for SIEMENS AERA MRI UNIT manufactured by Siemens Ag / Siemens Healthcare Gmbh.

Event Text Entries

[174128445] The non-sedated pt suffered a small blister on the dorsal aspect of the left hand and reddening to the nose. Burn damage discovered after mri exam. Pt reported feeling a warm sensation where his hose had been resting on his left hand. The pt was in the "superman" position, head first, prone with right hand above head. The thermal burn occurred due to skin-to-skin contact with large-caliber "body loops" due to the pt's nose touching the dorsal aspect of the left hand during the mri exam. The location of the burn was within the volume of the rf-transmit coil element (whole-body coil). The pt was screened for implants, devices, and other metallic objects for the potential to cause burns. No implants or objects were identified. Pt did not attempt to communicate with staff about heating / burn as it was happening. The emergency call button was provided and the staff kept in communication with the pt throughout the exam. Sar levels used - normal mode. Sequences included tsp & ge. Pt evaluated by physician. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5092072
• MDR Report Key: 9559262
• Date Received: 2020-01-06
• Date of Report: 2020-01-03
• Date of Event: 2019-12-31
• Date Added to Maude: 2020-01-07
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SIEMENS AERA MRI UNIT
• Generic Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Product Code: LNH
• Date Received: 2020-01-06
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SIEMENS AG / SIEMENS HEALTHCARE GMBH
• Manufacturer Address: US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-01-06