MAUDE Adverse Event Report: GENTHERM MEDICAL, LLC WARMAIR 135

Model Number	135
Medical Device Problem Code	Electrical Overstress (2924)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint (b)(4) received on january 23, 2026.This device is not available for evaluation.The device age is beyond its useful life.The age of this device is 19 years; its useful life is 5 years.
Event or Problem Description
The customer has alleged the cpu board is "burned".

• Brand Name: WARMAIR 135
• Common Device Name: WARMAIR 135
• Manufacturer (Section D): GENTHERM MEDICAL, LLC; 12011 mosteller rd; cincinnati OH 45241
• Manufacturer (Section G): GENTHERM MEDICAL, LLC; 12011 mosteller rd; cincinnati OH 45241
• Manufacturer Contact: angie gegner ; 12011 mosteller rd; cincinnati, OH 45241 ; 5133265228
• MDR Report Key: 24386941
• Report Number: 1516825-2026-00001
• Device Sequence Number: 16081727
• Product Code: DWJ
• UDI-Device Identifier: 10613031861860
• UDI-Public: (01)10613031861860
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K101148
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/19/2026

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: 135
• Device Catalogue Number: 86186
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (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