MAUDE Adverse Event Report: GENTHERM MEDICAL HEMOTHERM; HEATER/COOLER

Model Number	400CE
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer stated they had the device set to 36 and the system was measuring 41 degrees.No adverse event reported.Gentherm received a complaint (see complaint #'s (b)(4)).(b)(4) is being reported under a separate mdr # (1516825-2020-00008).
Event or Problem Description
Customer stated they had the device set to 36 and the system was measuring 41 degrees.No adverse event reported.

• Brand Name: HEMOTHERM
• Common Device Name: HEATER/COOLER
• Manufacturer (Section D): GENTHERM MEDICAL; 12011 mosteller road; cincinnati OH 45241
• MDR Report Key: 10794516
• Report Number: 1516825-2020-00009
• Device Sequence Number: 982487
• Product Code: DWC
• UDI-Device Identifier: 10613031860221
• UDI-Public: (01)10613031860221
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K122813
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/05/2020

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
• Operator of Device: No Information
• Device Model Number: 400CE
• Device Catalogue Number: 86022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2020
• Initial Report FDA Received Date: 11/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1