BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    46-SERIES

    MDR report key: 11999249 · Received June 15, 2021

    Report

    Report Number
    9616031-2021-00014
    Event Type
    Malfunction
    Date Received
    June 15, 2021
    Report Date
    October 5, 2021
    Manufacturer
    GETINGE DISINFECTION AB
    Product Code
    MEC
    UDI-DI
    07340153700086
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION

    Additional Manufacturer Narrative · 0

    GETINGE DEVICE WHICH PLAYED A ROLE IN AN EVENT WAS IDENTIFIED AS WASHER DISINFECTOR FROM 46-SERIES, WITH SERIAL NUMBER: (B)(6), MODEL NUMBER 46-5 AND THE UDI NUMBER (01)07340153700086. THE DEVICE WAS MANUFACTURED ON 3RD MAY 2018. THE DEVICE IS UNDER THE GETINGE SERVICE AGREEMENT AND LAST PREVENTIVE MAINTANANCE WAS DONE ONE MONTH BEFORE THE EVENT OCCURRED. ON 9TH JULY, 2021 GETINGE BECAME AWARE ABOUT THE EVENT THERE TROLLEY GET STOPPED WHILE DRIVING INTO THE WASHER¿S CHAMBER AND THE TOOL TRAY FALL TO THE FLOOR NEAR TO THE OPERATOR. WHEN REVIEWING REPORTABLE EVENTS OF THIS TYPE, WE WERE ABLE TO ESTABLISH THAT THERE WERE REPORTABLE COMPLAINTS FOR SIMILAR DEVICES MANUFACTURED BY GETINGE DISINFECTION AB WHERE LOADS FELL OFF OR ALMOST FELL OFF TO THE GROUND. HOWEVER, IT IS THE FIRST EVENT ON THAT ISSUE THAT WE HAVE RECEIVED FOR THE 46-SERIES WASHER DISINFECTOR. THE INFORMATION COLLECTED TO DATE AND AS A RESULT OF THE PERFORMED INVESTIGATION ALLOWED US TO ESTABLISH THAT DURING THE EVENT THE DEVICE AND A TROLLEY WHICH ARE WORKING IN THE SYSTEM WERE NOT UP TO THE MANUFACTURER SPECIFICATION. DURING THE INVESTIGATION COURSE WE CONCLUDED, THAT THE GUIDE FOR TROLLEY INSTALLED INSIDE THE CHAMBER WAS BENT AND NOT WORKING AS INTENDED. ADDITIONALLY IT WAS FOUND THAT THE TROLLEY FOR THE LOAD WAS OUT OF ADJUSTMENT. BENDING OF THE GUIDE RAIL COULD BE PROBABLY CAUSED BY THE SEVERAL FACTORS DESCRIBED AS UNKNOWN EXTERNAL FORCE RELATED TO THE OVERLOADED CARTS WHICH WERE PROBABLY PROCESSED IN THE WASHER DISINFECTOR, ROUGH HANDLING AND LOADING ACTIVITIES WHAT CAUSED THAT THE RAILS HAVEN¿T WITHSTANDING THE PRESSURE AND BENT. IN THE CONSEQUENCE THE TROLLEY COULD NOT BE LOADED TO THE CHAMBER AND HAS FALLEN ON THE FLOOR. NONE OF THE PROVIDED INFORMATION INDICATES THAT UPON THE EVENT OCCURRENCE THE DEVICE WAS BEING USED FOR PATIENT TREATMENT. THERE WAS NO INJURY REPORTED HOWEVER, WE DECIDED TO REPORT THE COMPLAINT BASED ON THE POTENTIAL OF HARM FOR THE USER IF THE SITUATION WAS TO REOCCUR. A GETINGE SERVICE TECHNICIAN REPAIRED THE DEVICE BY STRAIGHTENED THE GUIDE FOR THE TROLLEY, ADJUSTED THE TROLLEY AND ITS WHEELS AND RETURNED THE DEVICE WITH ITS ACCESSORY FOR USAGE IN FULLY OPERATIONAL CONDITIONS. WE BELIEVE THAT DEVICES IN THE MARKET ARE PERFORMING CORRECTLY OVERALL. GIVEN THE CIRCUMSTANCES AND THE FACT THAT THERE IS NO APPARENT TREND IN COMPLAINTS OF THIS NATURE, WE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE.

    Description of Event or Problem · 0

    MANUFACTURER`S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    THE ISSUE IS BEING INVESTIGATED BY MANUFACTURING SITE.

    Description of Event or Problem · 1

    ON (B)(6) 2021 GETINGE BECAME AWARE OF AN ISSUE WHERE THE GUIDE WAS BENT AND AS A CONSEQUENCE TOOL TRAY FELL DOWN NEAR THE OPERATOR. THERE WAS NO INJURY REPORTED, HOWEVER WE DECIDED TO REPORT THE ISSUE BASED ON A POTENTIAL AS THE TRAY FALLING OFF THE TROLLEY COULD BRING A HAZARDOUS SITUATION FOR THE OPERATOR AND LEAD TO SERIOUS BODY INJURY IF THE SITUATION WAS TO REOCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    897960 46-SERIES DISINFECTOR, MEDICAL DEVICES MEC GETINGE DISINFECTION AB 46-5 07340153700086

    Patients

    Seq Age Sex Outcome Treatment
    1