MAUDE Adverse Event Report: GENTHERM MEDICAL, LLC HEMOTHERM

Model Number 400CE

Device Problem Temperature Problem (3022)

Patient Problem Insufficient Information (4580)

Event Date 03/17/2022

Event Type  malfunction  

Manufacturer Narrative

Complaint #(b)(4) received.There were no allegations of patient harm.

Event Description

The customer claims this device would not heat during a procedure.The customer was able to secure another device and continue with the procedure but there was a delay in being able to come off bypass due to needing additional time to adequately rewarm.

Manufacturer Narrative

Device evaluation confirmed the heater was defective.The heater was replaced to correct.

• 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
• MDR Report Key: 14135424
• MDR Text Key: 298885967
• Report Number: 1516825-2022-00003
• Device Sequence Number: 1
• Product Code: DWC
• UDI-Device Identifier: 1061303186022
• UDI-Public: (01)1061303186022
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K122813
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/18/2022

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 Model Number: 400CE
• Device Catalogue Number: 86022
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/18/2022
• Initial Date FDA Received: 04/18/2022
• Supplement Dates Manufacturer Received: 03/18/2022
• Supplement Dates FDA Received: 06/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2019
• 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