MAUDE Adverse Event Report: GENTHERM MEDICAL, LLC BLANKETROL® LLL; SYSTEM, THERMAL REGULATING

Model Number	233
Health Effect - Clinical Code	Hyperthermia (1909)
Date of Event	06/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During bedside handoff patient's temperature noted to be 104.5 degrees fahrenheit.Blanketrol read that the water temperature was 40 degrees fahrenheit and appeared to be in working order.The representative noticed that the fan on the blanketrol machine was not functioning properly and the water being delivered to the cooling device was warm despite the blanketrol displaying that it was delivering water at 40 degrees fahrenheit.Machine was exchanged and new machine was noted be working correctly.Patient's temperature improved afterwards.

• Brand Name: BLANKETROL® LLL
• Common Device Name: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): GENTHERM MEDICAL, LLC; 12011 mosteller rd; cincinnati OH 45241
• MDR Report Key: 18102252
• Report Number: 18102252
• Device Sequence Number: 20222850
• Product Code: DWJ
• UDI-Device Identifier: 10613031861075
• UDI-Public: (01)10613031861075
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/11/2023
• Report Date (Section F): 07/11/2023

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: Health Professional
• Device Model Number: 233
• Device Catalogue Number: 86107
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/09/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/09/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 74 KG
• Date Report Sent to FDA: 07/11/2023