MAUDE Adverse Event Report: GENTHERM MEDICAL, LLC HEMOTHERM 400CE; HEATER COOLER DEVICE

Model Number	400CE
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer reported the hemohterm 400ce identified error code ee 02 (heat thermistor discrepancy - replace thermistor).Error was corrected.No patient/user injury reported.
Event or Problem Description
During a surgery, the hemotherm 400ce sent the ee02 error message indicating a heat thermistor discrepancy - replace thermistor.No patient/user injury was reported.

• Brand Name: HEMOTHERM 400CE
• Common Device Name: HEATER COOLER DEVICE
• Manufacturer (Section D): GENTHERM MEDICAL, LLC; 12011 mosteller; cincinnati, oh
• MDR Report Key: 9915397
• Report Number: 1516825-2020-00003
• Device Sequence Number: 14156903
• Product Code: DWC
• UDI-Device Identifier: 10613031860221
• UDI-Public: (01)10613031860221
• Combination Product (Y/N): N
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 03/25/2020

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: Health Professional
• Device Model Number: 400CE
• Device Catalogue Number: 86023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2020
• Initial Report FDA Received Date: 04/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1