inforMED
MalfunctionIRQ

HYDRATHERM HEATER - STANDARD, TRADITIONAL RACK SYSTEM, 12X HYDRAHEAT PACKS

Received Mar 26, 2021 · Event occurred Mar 15, 2021

Report 11574342 · MDR key 11574342

Device

Generic name

Unit, Heating, Powered

Model number

HT-R12-SRW

Catalog number

HT-R12-SRW

Product problems

  • Fluid/Blood Leak

Patient

36135 DA

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

THE DESIGN FLAW ON THE RICHMAR HYDRA HEAT PACK IS HAZARDOUS. WHEN THE END-USER LIFTS OPEN THE LID, THE COLLECTED WATER WOULD DRIP ON THE SIDE OF THE RACK SYSTEM, DRIBBLING STRAIGHT DOWN TO THE POWER CORD. THIS IS A VERY CONCERNING SAFETY ISSUE FOR OUR STAFF, SO WE ADVISED STAFF NOT TO PUT THIS DEVICE IN USE UNTIL IT IS CORRECTED. WE NOTIFIED ALL OUR HEALTH SYSTEM FACILITIES TO TAKE NOTE AND NOT USE THE DEVICE UNTIL ADDRESSED. MANUFACTURER RESPONSE FOR HYDRATHERM PACK HEATER, HYDRA THERM (PER SITE REPORTER). FROM MANUFACTURER: "THE HYDRATHERM HAS BEEN IN PRODUCTION SINCE 2015 AND HAS A ISO 60601-1 UL LISTING, THIS INTERNATIONAL ELECTRICAL SAFETY STANDARD COULD NOT BE CERTIFIED BY SGS (A THIRD-PARTY INDEPENDENT TESTING PROVIDER) IF IT WAS NOT ELECTRICALLY SAFE. CORRECT, CONDENSATION DOES OCCUR AS THE UNIT HEATS UP AND MAINTAINS TEMPERATURE. THIS WOULD BE FOUND IN ANY TRADITIONAL HEATING UNIT MODEL. THE UNIT IS INTENTIONALLY DESIGNED SO THE CONDENSATION FLOWS BACK INTO THE TANK. THE GLASS LID MUST BE OPENED ALL THE WAY, CREATING AN ANGLE FOR THE WATER TO DRAIN DOWN INTO THE TANK (AS OPPOSED TO POOLING IN THE GASKET AND OVERFLOWING DOWN THE BACK OR SIDE OF THE UNIT). IF THE LID DOES NOT ANGLE INTO THE TANK PLEASE LET US KNOW, SOMETHING COULD HAVE SHIFTED DURING SHIPPING. YOU CAN SEE THE ANGLE OF THE GLASS LID IN OUR HOW TO USE HYDRATHERM VIDEO SERIES." THE REP WHO SOLD THE UNIT, CAME UP WITH A SOLUTION TO ADDRESS THE SITUATION, BUY INSTALLING SEALS ON THE TOP OF THE UNIT TO PREVENT ANY WATER DRIPS FROM GETTING TO THE POWER SUPPLY.