AMSCO
Received Sep 19, 1997 · Event occurred Jul 5, 1997
Report 9680353-1997-00001 · MDR key 122060
Device
Generic name
Reliance Series Washer
Manufacturer
Hoplab Inc.Model number
430Catalog number
FL-XXXX
Lot number
NA
Patient
*
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 TO THE BACK OF THE RIGHT HAND (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 CONDITIONS ARE MET SIMULTANEOUSLY: THERMOSTAT FAILURE WITH CONTACTOR CLOSED DURING THE THERMAL RINSE PHASE; OPERATOR NOT FOLLOWING SAFETY WARNING AND OPENS CHAMBER DOOR BEFORE CYCLE COMPLETION; OPERATOR NOT WEARING RECOMMENDED PROTECTIVE EQUIPMENT (GLOVE AND FACE SHIELD) AS PER LABELING OF WASHER.
Remedial action
- Replace