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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENTHERM MEDICAL, LLC HEMOTHERM HEATER-COOLER, PRODUCT CODE: DWC

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GENTHERM MEDICAL, LLC HEMOTHERM HEATER-COOLER, PRODUCT CODE: DWC Back to Search Results
Model Number 400CE
Device Problem Pumping Stopped (1503)
Patient Problem Insufficient Information (4580)
Event Date 07/04/2022
Event Type  malfunction  
Event Description
During surgery, the device had a fault and it stopped pumping the water. Device was exchanged to continue procedure. No injury reported.
 
Manufacturer Narrative
Complaint (b)(4) received. There were no allegations of patient harm.
 
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Brand NameHEMOTHERM
Type of DeviceHEATER-COOLER, PRODUCT CODE: DWC
Manufacturer (Section D)
GENTHERM MEDICAL, LLC
12011 mosteller rd
cincinnati OH 45241
Manufacturer (Section G)
GENTHERM MEDICAL, LLC
12011 mosteller rd
cincininati OH 45241
Manufacturer Contact
angie gegner
12011 mosteller rd
cincinnati, OH 45241
5133265228
MDR Report Key15204544
MDR Text Key300653448
Report Number1516825-2022-00006
Device Sequence Number1
Product Code DWC
UDI-Device Identifier1061303186022
UDI-Public(01)1061303186022
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K122813
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation
Type of Report Initial
Report Date 08/09/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/10/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number400CE
Device Catalogue Number86022
Was Device Available for Evaluation? No
Date Manufacturer Received07/12/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/29/2021
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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