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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 Problems Break (1069); Smoking (1585)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Manufacturer Narrative

Gentherm received medwatch report #mw5085864 (complaint # (b)(4)) which stated the hemotherm device appeared to have smoke coming from the front of the device. Mdr investigation concluded the device was being used for treatment, no serious injury took place and the gentherm medical hemotherm device did fail to meet its specifications.

 
Event Description

From medwatch report: during a cardiothoracic surgical procedure, the hemotherm, a heating/cooling device with hoses that connect to the warming blanket which is under the pt. Was noted to be "smoking" from the front of the machine by the perfusionist. The device was immediately unplugged, disconnected from the warming blanket and removed from the surgery room. Biomedical engineering services found the "mother board" component within the hemotherm console to have been damaged.

 
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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 Key8672849
MDR Text Key147169471
Report Number1516825-2019-00007
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
PMA/PMN NumberK122813
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Type of Report Initial
Report Date 06/05/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/05/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number400CE
Device Catalogue Number86022
Was Device Available For Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/06/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/01/2018
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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