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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
Medical Device Problem Code Smoking (1585)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 12/03/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Gentherm received an allegation (b)(4) of a hemotherm that, during a procedure, the heater/cooler was being set to cool and made a popping noise followed by an electrical burn smell.The unit was replaced and the procedure finished with no patient harm.The unit has not been returned for evaluation.
 
Event or Problem Description
During a procedure, the hemotherm heater/cooler was being set to cool and made a popping noise followed by an electrical burn smell.The unit was replaced and the procedure finished with no patient harm.
 
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Brand Name
HEMOTHERM HEATER-COOLER
Common Device Name
HEATER-COOLER
Manufacturer (Section D)
GENTHERM MEDICAL, LLC
12011 mosteller
cincinnati OH 45241
MDR Report Key9506503
Report Number1516825-2019-00015
Device Sequence Number13953653
Product Code DWC
UDI-Device Identifier10613031860221
UDI-Public(01)10613031860221
Combination Product (Y/N)N
Initial Reporter StateMO
Initial Reporter CountryUS
PMA/510(K) Number
K122813
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date (Section B) 12/20/2019
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 Number400CE
Device Catalogue Number86022
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/03/2019
Initial Report FDA Received Date12/20/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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