MAUDE Adverse Event Report: JIANGMEN DACHENG MEDICAL EQUIPMENT CO., LTD. KOZEE

Model Number	M21505
Medical Device Problem Codes	No Audible Prompt/Feedback (2282); Output Problem (3005)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	08/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient went under a 6hr heart surgery.The hospital used 505 blower without blanket.The patient experienced a second degree burn on both legs.The hospital is claiming that our equipment did not have alarm or automatically stop when overheating.The hospital's biomed group did a test showing that our blower continued blowing even when the temperature at the air hose hitting 63 degrees.
Additional Manufacturer Narrative
Gentherm medical, llc., is representing the manufacturer and is submitting this report on their behalf.The injury occurred on the lower limb (both legs).The hospital was free hosing and not using a blanket as required with this warming device.This is a misuse case.Engineering checked the alarms, and they are working properly but the audio is low.From the report description and engineers' onsite feedback, the user did not use blankets but directly warmed the patient with the device hose.In the ifu, there are several warnings regarding the overheat, requiring using the device with blankets.The warning language specifically mentions: "fix all hoses, do not warm the patient without a body surface heating blanket." this is a misuse case.

• Brand Name: KOZEE
• Common Device Name: KOZEE
• Manufacturer (Section D): JIANGMEN DACHENG MEDICAL EQUIPMENT CO., LTD.; no. 8, jiaobei hengkeng south; jianghai district; jiangmen city, guangdong province 52904 0; CH 529040
• Manufacturer (Section G): JIANGMEN DACHENG MEDICAL EQUIPMENT CO., LTD.; no. 8, jiaobei hangkeng south; jianghai district; jiangmen city, guangdong province 52904 0; CH 529040
• Manufacturer Contact: lynne fu ; no. 8 jiaobei hengkeng south; jaingmen district; jiangmen city, guangdong province 52904-0 ; CH 529040
• MDR Report Key: 22902938
• Report Number: 3010168054-2025-00004
• Device Sequence Number: 21036168
• Product Code: DWJ
• UDI-Device Identifier: 08973920006730
• UDI-Public: 08973920006730
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: M21505
• Device Catalogue Number: 505
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2025
• Initial Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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