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U.S. Department of Health and Human Services

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

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GENTHERM MEDICAL, LLC HEMOTHERM 400CE HEATER-COOLER HEMOTHERM HEATER-COOLER Back to Search Results
Model Number 400CE
Device Problem Defective Device (2588)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/10/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6) received a call (cdr 60692) stating the hemotherm devices would not reach set temperature for rewarming. The unit was replaced and rewarming was continued. The issue did not cause any patient harm but did result in delay of surgery.
 
Event Description
Customer reported on (b)(6) 2019 that on (b)(6) 2019 the hemotherm device would not go above 34c. A replacement unit was brought in and warming continued. Customer reported that there was no patient harm but there was a delay in surgery.
 
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Brand NameHEMOTHERM 400CE HEATER-COOLER
Type of DeviceHEMOTHERM HEATER-COOLER
Manufacturer (Section D)
GENTHERM MEDICAL, LLC
12011 mosteller
cincinnati OH 45241
Manufacturer (Section G)
GENTHERM MEDICAL, LLC
12011 mosteller
cincinnati OH 45241
Manufacturer Contact
christina miracle
12011 mosteller
cincinnati, OH 45241
5133265295
MDR Report Key9604710
MDR Text Key200667639
Report Number1516825-2020-00002
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 Biomedical Engineer
Type of Report Initial
Report Date 01/17/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/18/2020
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? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/20/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2019
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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