MAUDE Adverse Event Report: THERMASOLUTIONS, INC. THERMASOLUTIONS, INC.; THERMOCHEM HT-1000

Model Number MT-1000

Device Problems Corroded (1131); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/17/2017

Event Type  malfunction  

Event Description

Temperature sensor error during set-up.Vendor discovered corrosion on internal thermostat located in water reservoir.Surgery could not be completed due to malfunction.

• Brand Name: THERMASOLUTIONS, INC.
• Type of Device: THERMOCHEM HT-1000
• Manufacturer (Section D): THERMASOLUTIONS, INC.; white bear lake MN
• MDR Report Key: 6269558
• MDR Text Key: 65597091
• Report Number: MW5067378
• Device Sequence Number: 1
• Product Code: MLW
• 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: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MT-1000
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR