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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENTHERM MEDICAL, LLC HEMOTHERM 400CE HEATER COOLER DEVICE

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GENTHERM MEDICAL, LLC HEMOTHERM 400CE HEATER COOLER DEVICE Back to Search Results
Model Number 400CE
Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Temperature Problem (3022)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/24/2020
Event Type  malfunction  
Manufacturer Narrative
Customer reported the hemohterm 400ce identified error code ee 02 (heat thermistor discrepancy - replace thermistor). Error was corrected. No patient/user injury reported.
 
Event Description
During a surgery, the hemotherm 400ce sent the ee02 error message indicating a heat thermistor discrepancy - replace thermistor. No patient/user injury was reported.
 
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Brand NameHEMOTHERM 400CE
Type of DeviceHEATER COOLER DEVICE
Manufacturer (Section D)
GENTHERM MEDICAL, LLC
12011 mosteller
cincinnati, oh
Manufacturer (Section G)
GENTHERM MEDICAL, LLC
12011 mosteller
cincinnati, oh
Manufacturer Contact
christina miracle
12011 mosteller
cincinnati, oh 
6125295
MDR Report Key9915397
MDR Text Key202551370
Report Number1516825-2020-00003
Device Sequence Number1
Product Code DWC
UDI-Device Identifier10613031860221
UDI-Public(01)10613031860221
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 Biomedical Engineer
Type of Report Initial
Report Date 03/25/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number400CE
Device Catalogue Number86023
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/24/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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