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

Model Number	400CE
Medical Device Problem Code	Insufficient Heating (1287)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer report was received on (b)(6) 2019 ((b)(4)) stating the hemtoherm heater-cooler would not reach maximum temperature.Unit has not been returned for evaluation.Customer reported there was no patient harm.
Event or Problem Description
A hemotherm will not reach maximum temperature.Another hemotherm device was used to continue with the procedure without incident.Customer reported there was no patient harm.
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 DEVICE
• 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 ; 8009897373
• MDR Report Key: 9290181
• Report Number: 1516825-2019-00013
• Device Sequence Number: 13919563
• Product Code: DWC
• UDI-Device Identifier: 10613031860221
• UDI-Public: (01)10613031860221
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 11/07/2019

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: N/A
• Device Lot Number: N/A
• 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: 10/08/2019
• Supplement Date Received by Manufacturer: 11/12/2019
• Initial Report FDA Received Date: 11/07/2019
• Supplement Report FDA Received Date: 03/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown