BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    86-SERIES

    MDR report key: 11655491 · Received April 13, 2021

    Report

    Report Number
    9616031-2021-00008
    Event Type
    Malfunction
    Date Received
    April 13, 2021
    Date of Event
    April 2, 2021
    Report Date
    May 18, 2021
    Manufacturer
    GETINGE DISINFECTION AB
    Product Code
    MEC
    UDI-DI
    07340153700277
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 2ND APRIL, 2021 GETINGE BECAME AWARE OF AN ISSUE RELATED TO AGS UNLOADING DEVICE USED TOGETHER WITH THE 8668 WASHER DISINFECTOR. AS IT WAS STATED, THE STOPPING PIN OF THE DEVICE WAS JAMMED IN THE DOWN POSITION, LEADING TO THE RACK TO FALL OFF. THERE WAS NO INFORMATION ABOUT ANY HARM OR DAMAGE DUE TO THE ISSUE, HOWEVER WE DECIDED TO REPORT THE EVENT IN ABUNDANCE OF CAUTION THAT ANY RACK FALLING OF THE DEVICE COULD CAUSE AN INJURY. DURING THE INVESTIGATION COURSE WE WERE ABLE TO ESTABLISH, THAT THE ROOT CAUSE OF THIS ISSUE WAS DEFINED AS STOPPING PIN JAMMED IN THE DOWN POSITION. THE STOP PIN BECAME STUCK DOWN DUE TO THE METAL COVER OF THE PIN BEING WRONGLY ASSEMBLED AND PREVENTING THE PIN MOVEMENT. AS THE UNIT WAS RE-INSTALLED ABOUT TWO WEEKS BEFORE THE EVENT OCCURRED, THE MOST LIKELY ROOT CAUSE OF THE EVENT WAS CONCLUDED AS INSTALLATION ERROR. THE DETAILED INSTRUCTION ABOUT THE INSTALLATION AND ADJUSTMENT OF THE PART AFFECTED IS PLACED IN THE INSTALLATION MANUAL FOR GETINGE AGS (DOC. 6001299502, CHAPTER 6.12). WE RECOMMENDED RETRAINING OF THE GETINGE TECHNICIAN WHO HAS PERFORMED THE DEVICE INSTALLATION. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE AFFECTED DEVICE DID NOT MEET ITS SPECIFICATION AS A MALFUNCTION OF THE END STOP PIN OCCURRED AND LED TO THE CART FALLING AND IN THIS WAY THE DEVICE CONTRIBUTED TO REPORTABLE EVENT. NONE OF THE PROVIDED INFORMATION INDICATES THAT UPON THE EVENT OCCURRENCE THE DEVICE WAS BEING USED FOR PATIENT TREATMENT. THE PROBLEM HAS BEEN RESOLVED BY ADJUSTMENT OF THE PIN COVER ON THE CONVEYOR. GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DO NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE NUMBER (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. DEVICE NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    ON 2ND APRIL, 2021 GETINGE BECAME AWARE OF AN ISSUE RELATED TO 8668 WASHER DISINFECTOR. AS IT WAS STATED, THE STOPPING PIN MALFUNCTIONED ON THE DEVICE LEADING TO RACK FELL OFF. THERE WAS NO INFORMATION ABOUT ANY HARM OR DAMAGE DUE TO THE ISSUE, HOWEVER WE DECIDED TO REPORT THE EVENT IN ABUNDANCE OF CAUTION THAT ANY RACK FALLING OF THE DEVICE COULD CAUSE AN INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556445 86-SERIES DISINFECTOR, MEDICAL DEVICES MEC GETINGE DISINFECTION AB 8668 07340153700277

    Patients

    Seq Age Sex Outcome Treatment
    1