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

Model Number	400CE
Medical Device Problem Code	Insufficient Heating (1287)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Gentherm received a report ((b)(4)) that the hemotherm heater/cooler would not heat above 34c.Unit was switched out and procedure was completed without further issue.No patient harm reported.Unit has not been returned for evaluation.
Event or Problem Description
Customer reported that during the rewarming portion of a procedure, the hemotherm device would not heat above 34c.The unit was replaced and the procedure concluded without incident.No patient harm was reported.
Additional Manufacturer Narrative
Device was evaluated and determined to have a defective heater.The heater was replaced to correct.

• Brand Name: HEMOTHERM
• Common Device Name: HEATER COOLER
• Manufacturer (Section D): GENTHERM MEDICAL, LLC; 12011 mosteller; cincinnati OH 45241
• Manufacturer (Section G): GENTHERM MEDICAL, LLC; 12011 mosteller; cincinnati OH 45241
• Manufacturer Contact: christina miracle ; 12011 mosteller; cincinnati, OH 45241 ; 5133265295
• MDR Report Key: 9506929
• Report Number: 1516825-2019-00016
• Device Sequence Number: 1839169
• Product Code: DWC
• UDI-Device Identifier: 10613031860221
• UDI-Public: (01)10613031860221
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2019

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 Expiration Date: 10/01/2018
• Device Model Number: 400CE
• Device Catalogue Number: 86022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2019
• Supplement Date Received by Manufacturer: 02/24/2020
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 03/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2018
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown