inforMED
MalfunctionMDZ

GETINGE

Received Mar 22, 2001 · Event occurred Feb 25, 2001

Report 9616031-2001-00001 · MDR key 322642

Device

Generic name

Washer/disinfector

Model number

8666

Catalog number

*

Lot number

*

Product problems

  • Fire
  • Smoking
  • Other (for use when an appropriate device code cannot be identified)

Patient

*

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

A MODEL 8666 WASHER/DISINFECTOR CAUGHT FIRE AND WAS DESTROYED BEYOND REPAIR WITHIN CENTRAL PROCESSING DEPT. THE FIRE WAS CONTAINED WITHIN THE ENCLOSURE OF THE WASHER. SOME SMOKE AND WATER DAMAGE OCCURRED TO THE AREA DUE TO THE ACTIVATION OF THE SPRINKLER SYSTEM. THE LOCAL FIRE DEPT PUT OUT THE FIRE AND ASSURED THE AREA WAS SAFE. EVACUATION WAS LIMITED TO THE IMMEDIATE AREA (BASEMENT OF HOSPITAL). NO ONE WAS INJURED. THE PROBLEM AND CAUSE IS CURRENTLY NOT FULLY KNOWN AND IS UNDER INVESTIGATION. THE UNIT WAS REMOVED FROM THAT FACILITY AND IS BEING RETAINED FOR INVESTIGATION PURPOSES.

Description of Event or Problem

HIGH WINDS AND ELECTRICAL STORMS WERE PRESENT DURING THE DAY OF THIS EVENT. OVER-VOLTAGE OR HIGH TRANSIENT CONDITIONS WERE LIKELY AT THE TIME OF THE INCIDENT. THE INVESTIGATION SHOWS THAT THERE WAS AN ADDITION OF A MODEL KNIGHT TRAK II PERISTALTIC PUMPING SYSTEM THAT WAS INTERFACED TO THE 8666 WASHER/DISINFECTOR. THE KNIGHT TRAK II SYSTEM IS MODULAR. A KNIGHT SIGNAL INTERFACE MODULE WAS INSTALLED WITHIN THE LOWER CABINETRY OF CO'S DEVICE. THIS MODULE PROVIDES AN INPUT AND OUTPUT INTERFACE BETWEEN CO'S EQUIPMENT AND THE KNIGHT PUMPING SYSTEM. THIS KNIGHT SIGNAL MODULE WAS IDENTIFIED AS BEING THE LIKELY ORIGIN OF THE FIRE, BASED UPON IT BEING THE MOST EXTENSIVELY DAMAGED OF ALL COMPONNENTS AND THE OBSERVED FIRE DAMAGE PATTERNS. THERE WERE NO DESIGN CHANGED MADE TO THE 8666 WASHER/DISINFECTOR THAT ARE RELATED TO THE EVENT. KNIGHT, INC IS NOT A MEDICAL DEVICE MFR NOR IS THEIR PUMPING SYSTEM A MEDICAL DEVICE. IT IS A SEPARATE SYSTEM. PRIMARILY, THESE PUMPING SYSTEMS ARE DISTRIBUTED TO LAUNDRY AND RESEARCH INDUSTRIES AND ARE CURRENTLY USED ON HIGH VOLUME, COMMERCIAL WASHING EQUIPMENT.