MAUDE Adverse Event Report: GENTHERM MEDICAL HEMOTHERM; HEATER/COOLER

Model Number	400CE
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported a heating malfunction occurred, the device stopped heating near the end of a surgical case.The device was set at 38 degrees, reached set temp at start of case but then dropped and would not rise to set point.The customer could not get the device to heat above 30 degrees even though the high and low heating led indicators are on.No adverse event reported.
Event or Problem Description
The customer reported a heating malfunction occurred, the device stopped heating near the end of a surgical case.The device was set at 38 degrees, reached set temp at start of case but then dropped and would not rise to set point.The customer could not get the device to heat above 30 degrees even though the high and low heating led indicators were on.No adverse event reported.

• Brand Name: HEMOTHERM
• Common Device Name: HEATER/COOLER
• Manufacturer (Section D): GENTHERM MEDICAL; 12011 mosteller road; cincinnati OH 45241
• MDR Report Key: 10905050
• Report Number: 1516825-2020-00010
• Device Sequence Number: 982035
• Product Code: DWC
• UDI-Device Identifier: 10613031860221
• UDI-Public: (01)10613031860221
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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 Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 11/25/2020

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: No Information
• Device Model Number: 400CE
• Device Catalogue Number: 86022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1