MAUDE Adverse Event Report: GENTHERM MEDICAL, LLC HEMOTHER HEATER COOLER

Model Number	400CE
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer report was received on (b)(6) 2019 (cdr # (b)(4)) stating the heomtherm heater-cooler alarmed with an ee03 code.It was determined the thermistor required replacement.
Event or Problem Description
A customer reported the hemotherm 400ce went down during a case with an ee03 error.No patient injury was reported.

• Brand Name: HEMOTHER HEATER COOLER
• Common Device Name: HEATER COOLER
• Manufacturer (Section D): GENTHERM MEDICAL, LLC; 12011 mosteller; cincinnati OH 45241
• MDR Report Key: 8983417
• Report Number: 1516825-2019-00012
• Device Sequence Number: 3330361
• Product Code: DWC
• UDI-Device Identifier: 10613031860221
• UDI-Public: (01)10613031860221
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 09/10/2019

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: 08/12/2019
• Initial Report FDA Received Date: 09/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1