BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GETINGE

    MDR report key: 322642 · Received March 22, 2001

    Report

    Report Number
    9616031-2001-00001
    Event Type
    Malfunction
    Date Received
    March 22, 2001
    Date of Event
    February 25, 2001
    Report Date
    March 21, 2001
    Manufacturer
    GETINGE DISINFECTION AB
    Product Code
    MDZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    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 · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12670 GETINGE WASHER/DISINFECTOR MDZ GETINGE DISINFECTION AB 8666 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *