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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 02/01/2020
Event Type  Malfunction  
Manufacturer Narrative

Customer reported via medwatch report that the unit alarmed showing an ee error code and water was not flowing. No patient or user injury reported.

 
Event Description

While on cardiopulmonary bypass (cpb), the heater-cooler alarmed and stopped functioning. The right hand side of the heater-cooler (heat side) showed the "ee" error code instead of the temperature and the water was not flowing. A reboot was attempted and resulted in the same error message. Water lines were quickly changed to a different heater-cooler. No patient injury was 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
cincinnati, oh 
3265295
MDR Report Key10110519
MDR Text Key196077437
Report Number1516825-2020-00005
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 ADMINISTRATOR/SUPERVISOR
Type of Report Initial
Report Date 04/30/2020
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
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/31/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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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