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

Model Number 233

Patient Problem Hyperthermia (1909)

Event Date 06/20/2023

Event Type  malfunction  

Event 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
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): GENTHERM MEDICAL, LLC; 12011 mosteller rd; cincinnati OH 45241
• MDR Report Key: 18102252
• MDR Text Key: 327741724
• Report Number: 18102252
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 10613031861075
• UDI-Public: (01)10613031861075
• 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: 07/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2023
• 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/11/2023
• Event Location: Hospital
• Date Report to Manufacturer: 11/09/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 13870 DA
• Patient Sex: Male
• Patient Weight: 74 KG