BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    86-SERIES

    MDR report key: 6962947 · Received October 19, 2017

    Report

    Report Number
    9616031-2017-00031
    Event Type
    Malfunction
    Date Received
    October 19, 2017
    Date of Event
    September 20, 2017
    Report Date
    March 27, 2018
    Manufacturer
    GETINGE DISINFECTION AB
    Product Code
    MEC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2016015 BY THE MANUFACTURER GETINGE DISINFECTION AB, (REGISTRATION NO. 9616031) ON BEHALF OF THE IMPORTER GETINGE USA, INC., (REGISTRATION NO. 3004147784). ADDITIONAL INFORMATION WILL BE PROVIDED UPON RESULTS OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2016015 BY THE MANUFACTURER GETINGE DISINFECTION AB, (REGISTRATION NO. 9616031) ON BEHALF OF THE IMPORTER GETINGE USA, INC., (REGISTRATION NO. 3004147784). THE MALFUNCTION OCCURRED ON UNLOADING CONVEYOR. THIS IS NOT A MEDICAL DEVICE BY ITSELF BUT AN ACCESSORY TO GETINGE 88-SERIES AND 86-SERIES WASHER DISINFECTOR DEVICE. THE CONVEYOR LOADS AND UNLOADS RACKS WITH MATERIAL TO BE DISINFECTED, INTO AND OUT OF THE DISINFECTOR. THAT IT IS ALL IT DOES AND IN THAT WAY IT HAS NO EFFECT ON THE CORE PERFORMANCE OF THE DISINFECTOR DEVICE. WE HAVE DETERMINED THE MEDICAL DEVICE GETINGE WASHER DISINFECTOR HAS NOT ATTRIBUTED TO THE EVENT AND ITSELF DID NOT PLAY ANY ROLE OF SIGNIFICANCE IN THE EVENT. GETINGE RECEIVED CUSTOMER COMPLAINT WHERE, AS STATED, THE ISSUE WITH UNLOADING CONVEYOR OCCURRED. NO INJURY OCCURRED AS A RESULT OF COMPLAINED ISSUE. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED THE UNLOADER WORKING IN THE SYSTEM WITH THE WASHER-DISINFECTOR DEVICE HAS NOT MET ITS SPECIFICATION AND IT CONTRIBUTED TO THE EVENT. WHEN THE EVENT OCCURRED THE DEVICE WAS BEING USED BY THE USER. DURING THE INVESTIGATION IT WAS FOUND THAT THE EVENT OCCURRED AS A RESULT OF TWO FACTORS: 1. THE PROGRAM NEEDS TO BE OVERRIDDEN BY THE PRESSING THE RESET BUTTON. THE RESET IS DONE BY THE OPERATOR IF THE CART IS NOT MOVED TO THE UNLOADER FROM THE WASHER DISINFECTOR OR ANY OTHER PROBLEM WITH THE CART TRANSFERRING. 2. THE END PIN OF THE UNLOADER NEEDS TO BE STUCK IN THE DOWN POSITION. WHEN THE PIN IS IN DOWN POSITION THERE IS NO MECHANICAL PROTECTION TO KEEP THE CART ON THE CONVEYOR, THEREFORE WHEN THE CART REACHES THE EDGE OF THE CONVEYOR IS NOT MECHANICALLY STOPPED AND IT FALLS OFF. IT WAS CONCLUDED THAT WHEN BOTH OF MENTIONED FACTORS APPEAR IN THE SAME TIME THE CART MAY NOT BE STOPPED AT THE END OF THE CONVEYOR AND COULD FALL DOWN ON THE FLOOR. A FIELD ACTION RELATED TO THIS ISSUE HAS BEEN LAUNCHED ON FEBRUARY 2018 AND ACCORDING TO THE FIELD ACTION PLAN UPDATE OF THE SOFTWARE AND CHANGE OF THE PIN WILL BE IMPLEMENTED FOR ALL DEVICES.

    Additional Manufacturer Narrative · 0

    THE FOLLOW UP REPORT (MFG REPORT NUMBER 9616031-2017-00031) IS SUBMITTED DUE TO THE MISSING F/U 1 AND IT IS SUBMITTED TO CORRECT THE ERROR IN NUMBERING. THERE IS NO NEW INFORMATION REGARDING THIS CASE. THE FINAL REPORT (F/U 3, 3004147784-2017-00031) WAS SENT ON 27/03/2018.THE DATE RECEIVED BY MFG IS THE DATE WHEN THE FDA REQUEST WAS RECEIVED (03/04/2025).

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2016015 BY THE MANUFACTURER GETINGE DISINFECTION AB, (REGISTRATION NO. 9616031) ON BEHALF OF THE IMPORTER GETINGE USA, INC., (REGISTRATION NO. 3004147784). THE EVENT IS STILL BEING INVESTIGATED. ADDITIONAL INFORMATION WILL BE PROVIDED UPON RESULTS OF THE INVESTIGATION.

    Description of Event or Problem · 0

    ON (B)(6) GETINGE BECOME AWARE OF AN INCIDENT WHERE ONE OF THE DEVICES WAS INVOLVED. AS IT WAS STATED BY THE CUSTOMER THE UNLOADER (WHICH IS NOT A MEDICAL DEVICE ITSELF BUT IT IS ATTACHED TO 86-SERIES WASHER DISINFECTOR WHICH MEDICAL DEVICE IS) FAILED DURING UNLOADING. WHEN THE INCIDENT OCCURRED CUSTOMER HAD TO RESET THE UNLOADER. AS STATED THE ONLY WAY TO RESET THE DEVICE WAS TO CLOSE THE CLEAN SIDE DOOR OF THE WASHER AND OPEN THE LOADING SIDE DOOR. THEREFORE THE CUSTOMER NOTICED THAT THE UNLOADER CAN TRY TO UNLOAD THE WASHER ALTHOUGH THE UNLOADING DOOR IS CLOSED. THERE WAS NO INJURY REPORTED DUE TO THIS INCIDENT, HOWEVER WE DECIDED TO REPORT THIS CASE IN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 0

    MANUFACTURER'S REFERENCE NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742908 86-SERIES DISINFECTOR, MEDICAL DEVICES MEC GETINGE DISINFECTION AB 8668

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other