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

Model Number 874

Device Problems Application Program Problem (2880); Temperature Problem (3022)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/28/2018

Event Type  malfunction  

Event 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
• Type of Device: PACK, HOT OR COLD, WATER CIRCULATING
• Manufacturer (Section D): CINCINNATI SUB-ZERO PRODUCTS, INC.; 12011 mosteller rd; cincinnati OH 45241
• MDR Report Key: 7725932
• MDR Text Key: 115221059
• Report Number: 7725932
• Device Sequence Number: 1
• Product Code: ILO
• UDI-Device Identifier: 10613031828740
• UDI-Public: (01)10613031828740(10)747313
• 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: 07/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 874
• Device Catalogue Number: 82874
• Device Lot Number: 747313
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/09/2018
• Event Location: Hospital
• Date Report to Manufacturer: 07/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1