THERMOFLECT * 5100-400

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-12-04 for THERMOFLECT * 5100-400 manufactured by Encompass Theraputic Support Systems.

Event Text Entries

[18489902] We scanned a patient with an mri while a hypothermia blanket with aluminum on one side. The blanket was mri conditional and it may be the reason our patient suffered a third degree burn. The patient will have to be grafted. The blanket is paper/blue on one side and aluminum/silver on the other. The silver side is intended to be placed away from the patient's skin. However, there is nothing on the blanket that would alert a provider that this should not come into contact with the patient's skin.
Patient Sequence No: 1, Text Type: D, B5

[18578575] We scanned a patient with an mri while a hypothermia blanket with aluminum on one side. The blanket was mri conditional and it may be the reason our patient suffered a third degree burn. The patient will have to be grafted. The blanket is paper/blue on one side and aluminum/silver on the other. The silver side is intended to be placed away from the patient's skin. However, there is nothing on the blanket that would alert a provider that this should not come into contact with the patient's skin.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1553108
• MDR Report Key: 1553108
• Date Received: 2009-12-04
• Date of Report: 2009-12-04
• Date of Event: 2009-11-22
• Report Date: 2009-12-04
• Date Reported to FDA: 2009-12-04
• Date Added to Maude: 2009-12-08
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: THERMOFLECT
• Generic Name: BLANKET, PATIENT, MRI
• Product Code: KME
• Date Received: 2009-12-04
• Model Number: *
• Catalog Number: 5100-400
• Lot Number: *
• ID Number: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ENCOMPASS THERAPUTIC SUPPORT SYSTEMS
• Manufacturer Address: 500 N. CENTRAL AVENUE SUITE 900 GLENDALE CA 91203 US 91203

Device Sequence Number: 2

• Brand Name: SIGNA HORIZON LX
• Generic Name: IMAGING, MAGNETIC RESONANCE SYSTEM
• Product Code: LNH
• Date Received: 2009-12-04
• Model Number: SINGA HORIZON LX
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: GE MEDICAL SYSTEMS, LLC
• Manufacturer Address: 3000 N. GRANDVIEW BLVD. WAUKESHA WI 53188 US 53188

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Other; 3. Required No Informationntervention	2009-12-04