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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENTHERM MEDICAL, LLC HEMOTHERM 400CE CARDIOPULMONARY BYPASS TEMPERATURE CONTROLLER

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GENTHERM MEDICAL, LLC HEMOTHERM 400CE CARDIOPULMONARY BYPASS TEMPERATURE CONTROLLER Back to Search Results
Model Number 400CE
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/11/2019
Event Type  malfunction  
Manufacturer Narrative
Allegation could not be confirmed. Device was returned with a new power supply board and past functional testing.
 
Event Description
It was reported that the hemotherm 400ce device "stopped pumping" during a procedure. Device was switched out and it was reported that there was no harm to the patient.
 
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Brand NameHEMOTHERM 400CE
Type of DeviceCARDIOPULMONARY BYPASS TEMPERATURE CONTROLLER
Manufacturer (Section D)
GENTHERM MEDICAL, LLC
12011 mosteller
cincinnati OH 45241
Manufacturer (Section G)
GENTHERM MEDICAL, LLC
12011 mosteller
cincinnati OH 45241
Manufacturer Contact
christina miracle
12011 mosteller
cincinnati, OH 45241
8009897373
MDR Report Key8501240
MDR Text Key149360701
Report Number1516825-2019-00003
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 health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/10/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/10/2019
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? Device Returned to Manufacturer
Date Returned to Manufacturer04/04/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/11/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/15/2016
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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