MAUDE Adverse Event Report: GENTHERM MEDICAL, LLC HEMOTHERM

Model Number 400CE

Device Problems Device Emits Odor (1425); Smoking (1585)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Device was evaluated at the facility by a gentherm technician on 03/23/2021.The f3 and f4 fuses on the power board had overheated.Power board, cpu board, heater and membrane panel replaced.Parts have returned and evaluation is pending.

Event Description

Customer reported that the hemotherm 400 ce had an issue during a case."the hemotherm started to smoke and filled the cardiac or with smoke and a very noxious odor.Biomed swapped out the unit and determined that it was the power supply board.".

• Brand Name: HEMOTHERM
• Type of Device: HEMOTHERM
• Manufacturer (Section D): GENTHERM MEDICAL, LLC; 12011 mosteller rd; cincinnati OH 45241
• Manufacturer Contact: angie gegner ; 12011 mosteller rd; cincinnati, OH 45241
• MDR Report Key: 11985996
• MDR Text Key: 259031285
• Report Number: 1516825-2021-00004
• Device Sequence Number: 1
• Product Code: DWC
• UDI-Device Identifier: 10613031860221
• UDI-Public: (01)10613031860221
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/14/2021

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2021
• Initial Date FDA Received: 06/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2019
• 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