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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 Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Temperature Problem (3022)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The customer stated that this hemotherm unit failed, the temperature would not go above 36°c. The unit was swapped out. No adverse event reported. (b)(4).
 
Event Description
The customer stated that the hemotherm unit failed, the temperature would not go above 36°c. The unit was swapped out. No adverse event reported.
 
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Brand NameHEMOTHERM
Type of DeviceHEATER/COOLER
Manufacturer (Section D)
GENTHERM MEDICAL
12011 mosteller road
cincinnati, oh
Manufacturer (Section G)
GENTHERM MEDICAL
12011 mosteller road
cincinnati, oh
Manufacturer Contact
christina miracle
12011 mosteller road
cincinnati, oh 
3265295
MDR Report Key10162989
MDR Text Key196076895
Report Number1516825-2020-00007
Device Sequence Number1
Product Code DWC
UDI-Device Identifier10613031860221
UDI-Public(01)10613031860221
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 user facility
Reporter Occupation Biomedical Engineer
Remedial Action Replace
Type of Report Initial
Report Date 06/17/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number400CE
Device Catalogue Number96022
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/28/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/19/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2016
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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