MAUDE Adverse Event Report: GENTHERM MEDICAL, LLC KOOL KIT® NEONATE; SYSTEM, THERMAL REGULATING

Model Number	950
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Hole/leak noted when water was infused through the blanket in preparation for admission of the patient.

• Brand Name: KOOL KIT® NEONATE
• Common Device Name: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): GENTHERM MEDICAL, LLC; 12011 mosteller rd; cincinnati OH 45241
• MDR Report Key: 16323160
• Report Number: 16323160
• Device Sequence Number: 8098579
• Product Code: DWJ
• UDI-Device Identifier: 10613031829501
• UDI-Public: (01)10613031829501
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/10/2023
• Report Date (Section F): 01/10/2023

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
• Device Model Number: 950
• Device Catalogue Number: 82950
• Device Lot Number: 19630
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/08/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/08/2023
• 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: Unknown
• Date Report Sent to FDA: 01/10/2023