MAUDE Adverse Event Report: GENTHERM MEDICAL, LLC HEMOTHERM; HEATER-COOLER, PRODUCT CODE: DWC

Model Number 400CE

Device Problem Insufficient Heating (1287)

Patient Problem Unspecified Heart Problem (4454)

Event Date 09/01/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4) received.There were no allegations of patient harm.The device was not returned to the manufacturer.The device was evaluated at the facility and determined to have a faulty heater assembly.

Event Description

The customer claims that during surgery, the user was trying to reach target temperature but its very much slow to heat.

• Brand Name: HEMOTHERM
• Type of Device: HEATER-COOLER, PRODUCT CODE: DWC
• 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: 15605327
• MDR Text Key: 302855060
• Report Number: 1516825-2022-00007
• Device Sequence Number: 1
• Product Code: DWC
• UDI-Device Identifier: 10613031860238
• UDI-Public: (01)10613031860238
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K122813
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• 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
• Date Manufacturer Received: 09/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2020
• 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