inforMED

24" WARMING CABINET

Received Feb 3, 2016 · Event occurred Jan 4, 2016

Report 1043572-2016-00010 · MDR key 5407278

Device

Generic name

Warming Cabinet

Product problems

  • Thermal Decomposition of Device
  • Device Emits Odor

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Additional Manufacturer Narrative

PHOTOGRAPHS OF THE UNIT WERE FORWARDED FOR EVALUATION BY STERIS. UPON INSPECTION OF THE PHOTOGRAPHS PROVIDED BY THE CUSTOMER, BRITTLE WIRES AND A DISCOLORATION OF THE FAN MOTOR WERE IDENTIFIED. ADDITIONALLY, THE PHOTOGRAPHS EVIDENCED THAT THE CONNECTORS AT THE FAN MOTOR WERE BROKEN AND FRAGMENTED. THE DAMAGE REVEALED IN THE PHOTOGRAPHS INDICATES THAT THE WARMING CABINET WAS NOT PROPERLY MAINTAINED. THE UNIT IS NOT UNDER STERIS CONTRACT AGREEMENT FOR MAINTENANCE. THE UNIT HAS BEEN IN USE AT THE USER FACILITY FOR OVER 17 YEARS. SECTION 4 OF THE MAINTENANCE MANUAL FOR THE WARMING CABINET STATES, "MAINTENANCE PROCEDURES DESCRIBED IN THIS SECTION SHOULD BE PERFORMED AT REGULAR INTERVALS, AS INDICATED. THE FREQUENCY, UNLESS OTHERWISE INDICATED, IS DETERMINED BY USAGE OF THE CABINET." ADDITION SECTION 4.2 ROUTINE INSPECTION STATES, " INSPECT CABINETRY FOR SIGNS OF DAMAGE OR MISALIGNED PARTS. REMOVE THE CONTROL TRAY FOR ACCESS TO ELECTRICAL CONNECTIONS. CHECK THE ELECTRICAL COMPONENTS FOR LOOSE WIRES, IMPROPER CONNECTIONS AND OTHER OBVIOUS DEFECTS [AND] REPLACE THE CONTROL TRAY. CHECK THE AIR-CIRCULATING FAN FOR OBVIOUS DEFECTS." THE CUSTOMER PURCHASED A NEW STERIS WARMING CABINET TO REPLACE THE UNIT SUBJECT OF THE REPORTED EVENT. THE NEW UNIT HAS BEEN INSTALLED AND IS OPERATING ACCORDING TO SPECIFICATION. STERIS HAS COMMUNICATED THE IMPORTANCE OF PROPERLY MAINTAINING THE WARMING CABINET WITH THE USER FACILITY.

Description of Event or Problem

THE USER FACILITY REPORTED THEIR 24" WARMING CABINET WAS EMITTING A BURNING SMELL. NO REPORT OF SMOKE. NO REPORT OF INJURY OR PROCEDURAL DELAY OR CANCELLATION.