MAUDE Adverse Event Report: CINCINNATI SUB ZERO / GENTHERM MEDICAL, LLC HEMOTHERM MACHINE; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number 400CE

Device Problem Energy Output Problem (1431)

Patient Problem Alteration in Body Temperature (4568)

Event Date 05/23/2022

Event Type  malfunction  

Event Description

While pt in open heart surgery his temperature could not be maintained and it was discovered that the hemotherm machine was not functioning/not heating.It was discovered that the machine had a faulty heating element.It was still under warranty.Fda safety report id # (b)(4).

• Brand Name: HEMOTHERM MACHINE
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CINCINNATI SUB ZERO / GENTHERM MEDICAL, LLC
• MDR Report Key: 14677093
• MDR Text Key: 294058587
• Report Number: MW5110281
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/09/2022

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 Operator: Health Professional
• Device Model Number: 400CE
• Device Catalogue Number: 86022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/10/2022
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Sex: Male