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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENTHERM MEDICAL, LLC HEMOTHERM HEATER/COOLER

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GENTHERM MEDICAL, LLC HEMOTHERM HEATER/COOLER Back to Search Results
Model Number 400CE
Device Problem Pumping Stopped (1503)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/01/2020
Event Type  Malfunction  
Manufacturer Narrative

Customer reported, the pump stopped working on this device during a procedure. The device was switched out with another hemotherm device and the procedure continued without any issues. No adverse event reported.

 
Event Description

Customer reported, the pump stopped working on this device during a procedure. The device was switched out with another hemotherm device and the procedure continued without any issues. No adverse event reported.

 
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Brand NameHEMOTHERM
Type of DeviceHEATER/COOLER
Manufacturer (Section D)
GENTHERM MEDICAL, LLC
12011 mosteller road
cincinnati OH 45241
Manufacturer (Section G)
GENTHERM MEDICAL, LLC
12011 mosteller road
cincinnati OH 45241
Manufacturer Contact
jodi fischesser
12011 mosteller road
cincinnati, OH 45241
5133265237
MDR Report Key11089618
MDR Text Key224839290
Report Number1516825-2020-00012
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 HEALTH PROFESSIONAL
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Remedial Action Other
Type of Report Initial
Report Date 12/29/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/29/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL Number400CE
Device Catalogue Number86022
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/01/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/01/2016
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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