MAUDE Adverse Event Report: GENTHERM MEDICAL, LLC MAXI-THERM LITE HYPER-HYPOTHERMIA BLANKET; PACK, HOT OR COLD, WATER CIRCULATING

Model Number 876

Device Problem Fluid/Blood Leak (1250)

Patient Problem Fever (1858)

Event Date 01/17/2023

Event Type  malfunction  

Event Description

Patient continuously febrile.Found to have a wet bed and puddles under patient.Unclear where leaking occurred or if controller unit also had a malfunction.Cooling blanket retained (no packaging).

• Brand Name: MAXI-THERM LITE HYPER-HYPOTHERMIA BLANKET
• Type of Device: PACK, HOT OR COLD, WATER CIRCULATING
• Manufacturer (Section D): GENTHERM MEDICAL, LLC; 12011 mosteller rd.; cincinnati OH 45241
• MDR Report Key: 16292451
• MDR Text Key: 308733566
• Report Number: 16292451
• Device Sequence Number: 1
• Product Code: ILO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 876
• Device Catalogue Number: 82876
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/19/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 6935 DA
• Patient Sex: Male