• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENTHERM MEDICAL, LLC HEMOTHER HEATER COOLER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

GENTHERM MEDICAL, LLC HEMOTHER HEATER COOLER Back to Search Results
Model Number 400CE
Device Problem Output Problem (3005)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/12/2019
Event Type  malfunction  
Manufacturer Narrative
A customer report was received on (b)(6) 2019 (cdr # (b)(4)) stating the heomtherm heater-cooler alarmed with an ee03 code. It was determined the thermistor required replacement.
 
Event Description
A customer reported the hemotherm 400ce went down during a case with an ee03 error. No patient injury was reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHEMOTHER HEATER COOLER
Type of DeviceHEATER 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
8009897373
MDR Report Key8983417
MDR Text Key204456890
Report Number1516825-2019-00012
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 09/10/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/10/2019
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? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/12/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-