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 Known Impact Or Consequence To Patient (2692)
Date of Event	07/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
User reported the hemotherm 400ce would not heat over 29c.Complaint #(b)(4)was opened and is being investigated.No adverse event was reported.
Event or Problem Description
User reported the hemotherm 400ce heater-cooler was heating slowly.The unit would not heat over 29c.No adverse event was reported.
Additional Manufacturer Narrative
Device 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 ; 8009897373
• MDR Report Key: 8881214
• Report Number: 1516825-2019-00010
• Device Sequence Number: 2361670
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2019

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2019
• Supplement Date Received by Manufacturer: 08/23/2019
• Initial Report FDA Received Date: 08/09/2019
• Supplement Report FDA Received Date: 03/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2019
• 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