MAUDE Adverse Event Report: GENTHERM MEDICAL, LLC HEMOTHERM; HEATER-COOLER

Model Number	400CE
Medical Device Problem Code	Insufficient Cooling (1130)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer report was received on (b)(6) 2019 ((b)(4)) stating the hemotherm heater-cooler stopped working during a procedure.The hemotherm device alarmed the "ee03" code for "cool thermistor discrepancy." the issue was corrected by replacing the thermistor.Customer reported there was no patient harm.
Event or Problem Description
Customer reported the hemotherm stopped working during a procedure and alarmed with the ee03 alarm code.

• Brand Name: HEMOTHERM
• Common Device Name: HEATER-COOLER
• Manufacturer (Section D): GENTHERM MEDICAL, LLC; 12011 mosteller; cincinnati OH 45241
• MDR Report Key: 9491513
• Report Number: 1516825-2019-00014
• Device Sequence Number: 19296182
• Product Code: DWC
• UDI-Device Identifier: 10613031860221
• UDI-Public: (01)10613031860221
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K122813
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/18/2019

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: Health Professional
• Device Model Number: 400CE
• Device Catalogue Number: 86022
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2019
• Initial Report FDA Received Date: 12/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1