MAUDE Adverse Event Report: GENTHERM MEDICAL, LLC HEMOTHERM

Model Number 400CE

Device Problem Temperature Problem (3022)

Patient Problem Insufficient Information (4580)

Event Date 12/03/2021

Event Type  malfunction  

Event Description

During a surgical procedure, the device would not heat.

Manufacturer Narrative

During a surgical procedure, the device would not heat.Customer evaluation determined the heater was defective.The customer replaced the heater to correct.This device was not returned to the manufacturer for evaluation.

• Brand Name: HEMOTHERM
• Type of Device: HEMOTHERM
• Manufacturer (Section D): GENTHERM MEDICAL, LLC; 12011 mosteller rd; cincinnati OH 45241
• Manufacturer (Section G): GENTHERM MEDICAL, LLC; 12011 mosteller rd; cincinnati OH 45241
• Manufacturer Contact: angie gegner ; 12011 mosteller rd; cincinnati, OH 45241 ; 5133265228
• MDR Report Key: 13928412
• MDR Text Key: 297971920
• Report Number: 1516825-2022-00001
• Device Sequence Number: 1
• Product Code: DWC
• UDI-Device Identifier: 1061303186022
• UDI-Public: (01)1061303186022
• Combination Product (y/n): Y
• Reporter Country Code: IN
• PMA/PMN Number: K122813
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 400CE
• Device Catalogue Number: 86023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1