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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 Problem Insufficient Heating (1287)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/28/2020
Event Type  malfunction  
Manufacturer Narrative
The customer reported a heating malfunction occurred, the device stopped heating near the end of a surgical case. The device was set at 38 degrees, reached set temp at start of case but then dropped and would not rise to set point. The customer could not get the device to heat above 30 degrees even though the high and low heating led indicators are on. No adverse event reported.
 
Event Description
The customer reported a heating malfunction occurred, the device stopped heating near the end of a surgical case. The device was set at 38 degrees, reached set temp at start of case but then dropped and would not rise to set point. The customer could not get the device to heat above 30 degrees even though the high and low heating led indicators were on. No adverse event reported.
 
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Brand NameHEMOTHERM
Type of DeviceHEATER/COOLER
Manufacturer (Section D)
GENTHERM MEDICAL
12011 mosteller road
cincinnati OH 45241
Manufacturer (Section G)
GENTHERM MEDICAL
12011 mosteller road
cincinnati OH 45241
Manufacturer Contact
jodi fischesser
12011 mosteller road
cincinnati, OH 45241
5133265237
MDR Report Key10905050
MDR Text Key231258422
Report Number1516825-2020-00010
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
Remedial Action Repair
Type of Report Initial
Report Date 11/25/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/25/2020
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 Manufacturer11/04/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/28/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2019
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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