AMSCO
Received Nov 11, 1998 · Event occurred Oct 9, 1998
Report 9680353-1998-00002 · MDR key 197368
Device
Generic name
Reliance Series Washer
Manufacturer
Steris Canada Corp.Model number
430Catalog number
FL-XXXX
Lot number
NA
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
*
- Burn(s)
Narrative
Description of Event or Problem
A. REPORTED INFO: FAULTY THERMOSTAT CAUSED SUMP WATER TO OVERHEAT AND EVAPORATE. THE STEAM ESCAPED THE CHAMBER WHEN THE ACCESS DOOR WAS OPENED AND THE OPERATOR WAS SLIGHTLY BURNED ON THE LEFT FOREARM (NOT A SERIOUS INJURY). B. REPORTABLE MALFUNCTION: STEAM CAUSED BY SUMP WATER EVAPORATION WILL ESCAPE FROM WASHER AND MIGHT CAUSE SEVERE BURNS IF ALL OF THE FOLLOWING CONDITION ARE MET SIMULTANEOUSLY: THERMOSTAT FAILURE WITH SUMP WATER HEATING DURING THERMAL RINSE PHASE; OPERATOR NOT FOLLOWING SAFETY WARNING AND OPENS CHAMBER DOOR BEFORE CYCLE COMPLETION. OPERATOR NOT WEARING RECOMMENDED PROTECTIVE EQUIPMENT (GLOVES, FACE SHIELD) AS PER LABELING.
Remedial action
- Replace