BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GETINGE 86 SERIES WASHER DISINFECTOR

    MDR report key: 6272345 · Received January 24, 2017

    Report

    Report Number
    9616031-2017-00001
    Event Type
    Injury
    Date Received
    January 24, 2017
    Date of Event
    January 9, 2017
    Report Date
    April 12, 2017
    Manufacturer
    GETINGE DISINFECTION AB
    Product Code
    MEC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    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). GETINGE RECEIVED A CUSTOMER COMPLAINT WHERE, AS STATED, AN OPERATOR RECEIVED SOFT TISSUE DAMAGE AFTER HER ARM BEING TRAPPED BETWEEN A TROLLEY THAT WAS MOVING BETWEEN THE LOADING CONVEYOR AND THE WASHER CHAMBER. WE HAVE NOT FOUND ANY SIMILAR INCIDENTS IN THE REVIEWED COMPLAINT HISTORY THEREFORE WE CURRENTLY VIEW THIS INCIDENT AS SINGLE, ISOLATED EVENT. GETINGE REPRESENTATIVE WHO ARRIVED ON SITE DID NOT FIND ANY EVIDENCES OF MALFUNCTION, ON THE CONTRARY THEY EVALUATED THE DEVICE AND CHECKED CONDITION AND FUNCTIONALITY OF THE EMERGENCY BUTTON AND CONFIRMED THE DEVICE WAS IN FULL WORKING CONDITION, OPERATING UP TO THE MANUFACTURER SPECIFICATION. TAKING THAT UNDER CONSIDERATION WE COULD ESTABLISH THAT THE INCIDENT WAS THE MOST LIKELY A RESULT OF A USE ERROR - THE OPERATOR LIKELY NOT HAVING MADE SURE THAT THE DEVICE HAD STOPPED BEFORE DECIDING TO GRAB AN OBJECT FROM THE INSIDE OF THE WASHER CHAMBER. HOWEVER IT WAS INDICATED THAT THE DEVICE WAS DIRECTLY INVOLVED IN THE REPORTABLE INCIDENT AND CAUSED THE INJURY. USER MANUAL FOR THE CONVEYOR (FSC) (504271000, REV. A) DESCRIBES HOW THE DEVICE SHOULD BE USED AND IT STATES THAT: "TO STOP THE RETURN CONVEYOR, PRESS THE STOP BUTTON AND RELEASE IT TO START THE CONVEYOR AGAIN." MOREOVER USER MANUAL FOR 86-SERIES WASHER DISINFECTORS (6001300302, REV. E) PROVIDE WITH WARNING IN THE CASE WHEN THE DEVICE IS EQUIPPED IN EXTERNAL LOADING EQUIPMENT AND IT CLEARLY STATES THAT IF THE WASHER IS USED WITH EXTERNAL LOADING EQUIPMENT (FOR EXAMPLE AGS) THE USER SHOULD WATCH OUT FOR MOVING SHUTTLES IN THE MARKED AREA. IF THE FACILITY STAFF WOULD FOLLOW THE INSTRUCTION GIVEN IN THE USER MANUAL IT IS CONSIDERED HIGHLY PROBABLE THAT THIS EVENT WOULD HAVE BEEN AVOIDED. WE HAVE REPORTED THIS EVENT IN ABUNDANCE OF CAUTION EVEN ALTHOUGH THERE WAS NO SERIOUS INJURY OR WORSE. (B)(4).

    Description of Event or Problem · 0

    GETINGE BECOME AWARE OF AN INCIDENT OCCURRED WITH ONE OF OUR DEVICES. IN THE INCIDENT WERE INVOLVED TWO OF OUR PRODUCTS: GETINGE 86-SERIES WASHER DISINFECTOR AND COMPATIBLE WITH IT LOADING EQUIPMENT (FSC - FREE STANDING CONVEYOR - AN AUTOMATIC RETURN CONVEYOR FOR TROLLEYS). AS IT WAS REPORTED BY THE CUSTOMER THAT FOLLOWING EVENT LED UP TO THE INJURY: WASHER CHAMBER WAS LOADED AND WAS RUNNING A CYCLE. THE FSC WAS LOADED WITH A CART WAITING FOR THE WASHER TO CALL FOR IT. ONCE THE WASHER HAS COMPLETED THE CYCLE, THE UNLOADING CONVEYOR REMOVED THE CART FROM THE CHAMBER. THEN THE WASHER STARTED TO CLOSE THE DOOR. INJURED PERSON (IP) HAD NOTICED A BOWL SITTING IN THE BOTTOM OF THE CHAMBER AND WALKED AROUND TO THE "IN FEED" SIDE OF THE MACHINE. SHE THOUGHT SHE HAS PRESSED THE E-STOP BUTTON OR THAT THE MACHINE WAS STOPPED. (UNCLEAR ON THIS DETAIL) IP HAS REACHED IN BETWEEN THE WAITING CART ON THE FSC AND THE WASHER TO RETRIEVE THE BOWL IN THE WASHER. THE FSC THEN BEGAN TO DRIVE THE CART INTO THE WASHER AND HAS HIT OR CRUSHED IP ARM/HAND. FROM FURTHER INFORMATION PROVIDED BY THE ORIGINATOR, IT IS KNOWN THAT THE INJURED PERSON ATTENDED TO THE EMERGENCY ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57002 GETINGE 86 SERIES WASHER DISINFECTOR MEC MEC GETINGE DISINFECTION AB 8668

    Patients

    Seq Age Sex Outcome Treatment
    1 Other