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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 Smoking (1585); Protective Measures Problem (3015)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
Complaint (b)(4) received. There were no allegations of patient harm. To date, the device has not returned for evaluation.
 
Event Description
Customer reports that during heating, the electrical hazard alarm, in the operating room, was activated and the device began to emit smoke. The device failed to heat the water and the exchanger was replaced with another to continue the procedure.
 
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Brand NameHEMOTHERM
Type of DeviceHEMOTHERM
Manufacturer (Section D)
GENTHERM MEDICAL, LLC
12011 mosteller rd
cincinnati OH 45241
Manufacturer (Section G)
GENTHERM MEDICAL, LLC
12011 mosteller rd
cincinnati OH 45241
Manufacturer Contact
angie gegner
12011 mosteller rd
cincinnati, OH 45241
5133265228
MDR Report Key12308178
MDR Text Key267720386
Report Number1516825-2021-00011
Device Sequence Number1
Product Code DWC
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 distributor
Reporter Occupation
Type of Report Initial
Report Date 08/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/11/2021
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? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/21/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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