inforMED
MalfunctionECG

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

430

Catalog 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