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U.S. Department of Health and Human Services

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

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GENTHERM MEDICAL, LLC HEMOTHERM HEATER/COOLER Back to Search Results
Model Number 400CE
Device Problems Insufficient Heating (1287); Failure to Power Up (1476)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/27/2021
Event Type  malfunction  
Manufacturer Narrative
During surgery the machine heated the water to 42°c, but when the perfusionist turned on the pump, the heater turned off and it never turn on again. The temperature dropped to 30°c but the setpoint was in 42°c. Later, they checked the machine and when turned on the pump in the heater mode, the machine did not heat the water. But if they stop the pump, the heater started to heat. No adverse event reported.
 
Event Description
During surgery the machine heated the water to 42°c, but when the perfusionist turned on the pump, the heater turned off and it never turn on again. The temperature dropped to 30°c but the setpoint was in 42°c. Later, they checked the machine and when turned on the pump in the heater mode, the machine did not heat the water. But if they stop the pump, the heater started to heat. No adverse event reported.
 
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Brand NameHEMOTHERM
Type of DeviceHEATER/COOLER
Manufacturer (Section D)
GENTHERM MEDICAL, LLC
12011 mosteller road
cincinnati OH 45241
Manufacturer Contact
jodi fischesser
12011 mosteller road
cincinnati, OH 45241
5133265237
MDR Report Key11373254
MDR Text Key244396928
Report Number1516825-2021-00002
Device Sequence Number1
Product Code DWC
UDI-Device Identifier10613031860221
UDI-Public(01)10613031860221
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122813
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number400CE
Device Catalogue Number86022
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/15/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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