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 reported they experienced a heater cooler concern on (b)(6) 2020.Profusion noted on the cooling function they had set the device to 36 and the system was measuring 41 degrees.Since the device was only being used for cooling (and a different device was being used for heating), the heating set point (on the cooling device) was lowered to the lowest setting to allow the procedure to continue rather than swapping the device out during the case.No adverse event reported.Gentherm received a complaint (see complaint #'s (b)(4)).(b)(4) is being reported under a separate mdr # (1516825-2020-00009).
Event or Problem Description
Customer reported they experienced a heater cooler concern on (b)(6) 2020.Profusion noted on the cooling function they had set the device to 36 and the system was measuring 41 degrees.Since the device was only being used for cooling (and a different device was being used for heating), the heating set point (on the cooling device) was lowered to the lowest setting to allow the procedure to continue rather than swapping the device out during the case.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: 10793084
• Report Number: 1516825-2020-00008
• Device Sequence Number: 13698664
• 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
• Remedial Action: Repair
• 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