MAUDE Adverse Event Report: GENTHERM MEDICAL, LLC HEMOTHERM

Model Number	400CE
Health Effect - Clinical Code	Alteration in Body Temperature (4568)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint #(b)(4) received.The customer concluded the heating element was not functioning.There were no allegations of patient harm.To date, the device has not returned for evaluation.
Event or Problem Description
The perfusionist had the patient on bypass and noticed temperature of the patient was low, the device set point was at 37 but the actual temperature was 32.The customer checked the flow indicator and it was showing forward flow.The device was changed out with blanketrol devices without incident.The hemotherm 400ce device was sent to biomed to help diagnose issue.Biomed determined the heating element was not functioning.
Additional Manufacturer Narrative
The device was returned for evaluation on august 4, 2021.The customer issue was confirmed; the heater was defective.The heater was replaced to correct.

• Brand Name: HEMOTHERM
• Common Device Name: HEMOTHERM
• Manufacturer (Section D): GENTHERM MEDICAL, LLC; 12011 mosteller rd.; cincinnati OH 45241
• Manufacturer Contact: angie gegner ; 12011 mosteller rd; cincinnati, OH 45241
• MDR Report Key: 12170349
• Report Number: 1516825-2021-00008
• Device Sequence Number: 4157907
• Product Code: DWC
• UDI-Device Identifier: 10613031860221
• UDI-Public: (01)10613031860221
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2021

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
• Device Model Number: 400CE
• Device Catalogue Number: 86022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2021
• Supplement Date Received by Manufacturer: 06/17/2021
• Initial Report FDA Received Date: 07/14/2021
• Supplement Report FDA Received Date: 12/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown