MalfunctionMLW
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Received Nov 15, 2011 · Event occurred Nov 3, 2011
Report 2366898 · MDR key 2366898
Device
Generic name
Thermochem Ht 1000r
Manufacturer
ThermasolutionsModel number
HT1000RCatalog number
*
Lot number
*
Product problems
- Break
- Device Inoperable
- Defective Component
- Device Displays Incorrect Message
Patient
43 YR
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
SIXTY MINUTES INTO A NINETY MINUTE HYPERTHERMIC INTRAPERITONEAL CHEMOPERFUSION (HIPEC) PROCEDURE, THE THERMOCHEM HT 1000R DEVICE STOPPED FUNCTIONING. THE DEVICE WAS ON LOAN FROM THE COMPANY THERMASOLUTIONS. THE FOLLOWING NOTICE WAS ON THE VIDEO SCREEN "NO VIDEO INPUT." THE VIDEO CABLE AT THE REAR OF THE DEVICE WAS NOTICED TO BE DEFECTIVE AND DAMAGED. WE CALLED THE COMPANY REP AND TOOK STEPS VIA PHONE INSTRUCTIONS TO BRING THE DEVICE BACK ON LINE. THE PROCEDURE WAS FINISHED WITHOUT FURTHER ISSUES.