MAUDE Adverse Event Report: CINCINNATI SUB-ZERO PRODUCTS, INC. MAXI-THERM®LITE; PACK, HOT OR COLD, WATER CIRCULATING

Model Number	874
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/28/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Cooling blanket was being used as part of total body cooling system.Blanket malfunctioned and did not maintain the programmed temperature.Cooling blanket was removed and replaced by a new cooling blanket.

• Brand Name: MAXI-THERM®LITE
• Common Device Name: PACK, HOT OR COLD, WATER CIRCULATING
• Manufacturer (Section D): CINCINNATI SUB-ZERO PRODUCTS, INC.; 12011 mosteller rd; cincinnati OH 45241
• MDR Report Key: 7725932
• Report Number: 7725932
• Device Sequence Number: 1108157
• Product Code: ILO
• UDI-Device Identifier: 10613031828740
• UDI-Public: (01)10613031828740(10)747313
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/09/2018
• Report Date (Section F): 07/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 874
• Device Catalogue Number: 82874
• Device Lot Number: 747313
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/27/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 07/09/2018