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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENTHERM MEDICAL, LLC HEMOTHERM

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GENTHERM MEDICAL, LLC HEMOTHERM Back to Search Results
Model Number 400CE
Device Problems Display or Visual Feedback Problem (1184); No Flow (2991)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Malfunction  
Manufacturer Narrative

Complaint# (b)(4) received. There were no allegations of patient harm. Device has not yet returned for evaluation.

 
Event Description

Customer claims their hemotherm 400ce was not flowing and froze up during a procedure; "the perfusionist had been running it on the hot side of the device for a case and when it was time to switch it over to the cold side, the device started alarming. It was then they noticed the coil had iced up and the water was not flowing. " a second device was used to finish out the case, no claim of injury to the patient.

 
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Brand NameHEMOTHERM
Type of DeviceHEMOTHERM
Manufacturer (Section D)
GENTHERM MEDICAL, LLC
12011 mosteller rd
cincinnati OH 45241
Manufacturer Contact
angie gegner
12011 mosteller rd
cincinnati, OH 45241
MDR Report Key12170340
MDR Text Key263462132
Report Number1516825-2021-00007
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
Type of Report Initial
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/14/2021
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 Answer Provided
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/16/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/10/2021
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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