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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
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 11/24/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Customer called in from the or with the hemotherm 400ce not pumping water.The customer was walked through evaluating the fuses on the power supply board.During the evaluation, it was discovered the device had a blown 20a fuse.The customer was able to replace the fuse to correct the malfunction and continue with the case without further incident.No adverse event reported.
 
Event or Problem Description
Customer called in from the or with the hemotherm 400ce not pumping water.The customer was walked through evaluating the fuses on the power supply board.During the evaluation, it was discovered the device had a blown 20a fuse.The customer was able to replace the fuse to correct the malfunction and continue with the case without further incident.No adverse event reported.
 
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Brand Name
HEMOTHERM
Common Device Name
HEATER/COOLER
Manufacturer (Section D)
GENTHERM MEDICAL, LLC
12011 mosteller road
cincinnati OH 45241
MDR Report Key11049686
Report Number1516825-2020-00011
Device Sequence Number1193147
Product Code DWC
UDI-Device Identifier10613031860221
UDI-Public(01)10613031860221
Combination Product (Y/N)N
Initial Reporter CountryID
PMA/510(K) Number
K122813
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial
Report Date (Section B) 12/21/2020
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 Number400CE
Device Catalogue Number86022
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/24/2020
Initial Report FDA Received Date12/21/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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