inforMED
MalfunctionECG

AMSCO

Received Nov 11, 1998 · Event occurred Oct 9, 1998

Report 9680353-1998-00002 · MDR key 197368

Device

Generic name

Reliance Series Washer

Model number

430

Catalog 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