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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENTHERM MEDICAL, LLC HEMOTHERM

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GENTHERM MEDICAL, LLC HEMOTHERM Back to Search Results
Model Number 400CE
Device Problems Device Emits Odor (1425); Smoking (1585)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
Device was evaluated at the facility by a gentherm technician on 03/23/2021.The f3 and f4 fuses on the power board had overheated.Power board, cpu board, heater and membrane panel replaced.Parts have returned and evaluation is pending.
 
Event Description
Customer reported that the hemotherm 400 ce had an issue during a case."the hemotherm started to smoke and filled the cardiac or with smoke and a very noxious odor.Biomed swapped out the unit and determined that it was the power supply board.".
 
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Brand Name
HEMOTHERM
Type of Device
HEMOTHERM
Manufacturer (Section D)
GENTHERM MEDICAL, LLC
12011 mosteller rd
cincinnati OH 45241
Manufacturer Contact
angie gegner
12011 mosteller rd
cincinnati, OH 45241
MDR Report Key11985996
MDR Text Key259031285
Report Number1516825-2021-00004
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 04/14/2021
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
Device Operator No Information
Device Model Number400CE
Device Catalogue Number86022
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/15/2021
Initial Date FDA Received06/11/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/25/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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