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

Model Number	400CE
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer reported the unit started draining during a procedure.No injury reported.Device received and evaluated: debris was found in heat outlet solenoid and the power cord was altered.Both issues were corrected.
Event or Problem Description
Customer reported issue: during a procedure while in heating mode the heat reservoir began to empty.

• Brand Name: HEMOTHERM
• Common Device Name: HEATER COOLER DEVICE
• Manufacturer (Section D): GENTHERM MEDICAL, LLC; 12011 mosteller; cincinnati, oh
• MDR Report Key: 9924829
• Report Number: 1516825-2020-00004
• Device Sequence Number: 14155150
• 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: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 04/03/2020

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: 86022
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2020
• Initial Report FDA Received Date: 04/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1