MAUDE Adverse Event Report: GENTHERM MEDICAL, LLC HEMOTHERM; HEATER/COOLER

Model Number 400CE

Device Problem Insufficient Heating (1287)

Patient Problem Alteration in Body Temperature (4568)

Event Date 02/11/2021

Event Type  malfunction  

Manufacturer Narrative

Per the distributor (terumo): the customer was trying to warm a patient.The customer set the device water temperature at 37 degrees celsius.The customer noted very slow movement in the patient's core temperature.The customer then set the device temperature to 38 degrees celsius.They noted the patient's core temperature was extremely slow in movement and set the device temperature at 39 degrees celsius.The device water temperature did not move above 36 degrees celsius.The customer noted it took 42 minutes for the patient's core temperature to move from 34 to 36 degrees celsius.No adverse event reported.

Event Description

The customer was trying to warm a patient.The customer set the device water temperature at 37 degrees celsius.The customer noted very slow movement in the patient's core temperature.The customer then set the device temperature to 38 degrees celsius.They noted the patient's core temperature was extremely slow in movement and set the device temperature at 39 degrees celsius.The device water temperature did not move above 36 degrees celsius.The customer noted it took 42 minutes for the patient's core temperature to move from 34 to 36 degrees celsius.No adverse event reported.

• Brand Name: HEMOTHERM
• Type of Device: HEATER/COOLER
• Manufacturer (Section D): GENTHERM MEDICAL, LLC; 12011 mosteller road; cincinnati OH 45241
• Manufacturer Contact: christina miracle ; 12011 mosteller road; cincinnati, OH 45241 ; 5133265295
• MDR Report Key: 11462713
• MDR Text Key: 244396458
• Report Number: 1516825-2021-00003
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122813
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 400CE
• Device Catalogue Number: 86022
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/11/2021
• Initial Date FDA Received: 03/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1