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

Model Number 400CE

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/21/2022

Event Type  malfunction  

Event Description

During operation there is a leak in the cold water reservoir.After checking, it was caused by a cracked part in the reservoir.

Manufacturer Narrative

Complaint #(b)(4) received.There were no allegations of patient harm.The customer claims during operation, there is a leak in the cold water reservoir.After checking, it was caused by a cracked part in the reservoir.The device was not made available for evaluation.

Manufacturer Narrative

Device was received on 4/11/2023 and evaluated on 4/13/2023.The evaluation confirmed the issue; the device was leaking water from the bulkhead fitting at the reservoir.Service replaced the reservoir assembly to correct.

• Brand Name: HEMOTHERM
• Type of Device: HEATER-COOLER
• 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: 15828181
• MDR Text Key: 307797925
• Report Number: 1516825-2022-00008
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): Y
• Reporter Country Code: ID
• 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,Followup
• Report Date: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2022
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2022
• 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