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

Model Number 233

Device Problems Loss of Power (1475); Device Displays Incorrect Message (2591)

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

Event Date 01/28/2020

Event Type  malfunction  

Event Description

Patient was febrile with temp of 39+ degrees celsius.Blanketrol machine used for cooling blanket suddenly stopped working.Code on machine said "check probe" but probe was definitely in appropriate place.We tried to trouble shoot the machine but were ultimately unable to restart it.

• Brand Name: BLANKETROL® LLL
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): CINCINNATI SUB-ZERO PRODUCTS, INC.; 12011 mosteller rd; 3rd floor; blue ash OH 45241
• MDR Report Key: 9659175
• MDR Text Key: 177369214
• Report Number: 9659175
• 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
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 233
• Device Catalogue Number: 86107
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/29/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 15695 DA