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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENTHERM MEDICAL HEMOTHERM HEATER/COOLER

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GENTHERM MEDICAL HEMOTHERM HEATER/COOLER Back to Search Results
Model Number 400CE
Device Problems Device Displays Incorrect Message (2591); No Flow (2991)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/31/2020
Event Type  Malfunction  
Manufacturer Narrative

Customer reported device showed error code "ee" on the heat side. No adverse event reported.

 
Event Description

Customer states that while on cardiopulmanary bypass (cbp), heater cooler alarmed and stopped functioning. The right hand side of heater cooler (heat side) showed "ee" instead of temperature, and water was not flowing. User attempted a reboot resulting in the same error message. Waterlines were quickly changed to a different cooler. No adverse event reported.

 
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Brand NameHEMOTHERM
Type of DeviceHEATER/COOLER
Manufacturer (Section D)
GENTHERM MEDICAL
12011 mosteller road
cincinnati, oh
Manufacturer (Section G)
GENTHERM MEDICAL
12011 mosteller road
cincinnati, oh
Manufacturer Contact
christina miracle
12011 mosteller road
cincinnati, oh 
3265295
MDR Report Key10110414
MDR Text Key204455591
Report Number1516825-2020-00006
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK122813
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 06/02/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/02/2020
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
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/01/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/01/2016
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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