MAUDE Adverse Event Report: CINCINNATI SUB-ZERO PRODUCTS, INC. BLANKETROL LLL; SYSTEM, THERMAL REGULATING

Model Number 233

Device Problem Temperature Problem (3022)

Patient Problem Insufficient Information (4580)

Event Date 09/15/2020

Event Type  malfunction  

Event Description

Blanketrol® lll thermal regulating system giving consistent water temperature of 42 degrees during cooling and rewarming procedure.Esophageal probe changed and black cables on side were reinserted in order for fan to start cooling water temperature down.

Event Description

Blanketrol® lll thermal regulating system giving consistent water temperature of 42 degrees celsius during cooling and rewarming procedure.Esophageal probe changed and black cables on side were reinserted in order for fan to start cooling water temperature down.

• Brand Name: BLANKETROL LLL
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): CINCINNATI SUB-ZERO PRODUCTS, INC.; 12011 mosteller rd 3rd floor; cincinnati OH 45241
• MDR Report Key: 10754869
• MDR Text Key: 213661550
• Report Number: 10754869
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 233
• Device Catalogue Number: 86107
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/14/2020
• Date Report to Manufacturer: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 3 DA