BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    91E-SERIES

    MDR report key: 12580029 · Received October 5, 2021

    Report

    Report Number
    9616031-2021-00030
    Event Type
    Malfunction
    Date Received
    October 5, 2021
    Date of Event
    September 27, 2021
    Report Date
    November 22, 2021
    Manufacturer
    GETINGE DISINFECTION AB
    Product Code
    MEC
    UDI-DI
    07340153710054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    ON 27TH SEPTEMBER, 2021, GETINGE BECAME AWARE OF AN ISSUE WITH AN INSTRUMENT WASH CART, PART NUMBER 6002116701. THE WASH CART WAS USED TOGETHER WITH WASHER DISINFECTOR 9127E, WITH SERIAL NUMBER (B)(6), UDI NUMBER (B)(4). THE DEVICE WAS MANUFACTURED ON 8TH JUNE, 2021 AND INSTALLED IN THE FACILITY ON 10TH SEPTEMBER, 2021. AT THE TIME OF FAILURE OCCURRED THE UNIT WAS UNDER WARRANTY. WE WERE ABLE TO ESTABLISH THAT THE CUSTOMER PRODUCT COMPLAINT IS RELATED TO A LOAD WHICH FELL OFF THE INSTRUMENT WASH CART, PART NUMBER 6002116701 DUE TO THE WHEEL ASSEMBLY MISSING. THE REVIEW OF REPORTABLE EVENTS REGISTERED IN THE COMPANY¿S COMPLAINT HANDLING SYSTEM WITHIN LAST 5 YEARS WAS PERFORMED. WHEN REVIEWING REPORTABLE EVENTS OF THIS TYPE, WE WERE ABLE TO ESTABLISH THAT WE HAVE REGISTERED REPORTABLE COMPLAINT FOR MANUAL TROLLEY WHERE LOADS FELL OFF TO THE GROUND DUE TO WHEEL ASSEMBLY MISSING. HOWEVER, IT IS THE FIRST EVENT ON THAT ISSUE THAT WE HAVE RECEIVED FOR THE INSTRUMENT WASH CART WITH PART NUMBER 6002116701. DURING THE INVESTIGATION COURSE WE WERE ABLE TO DETERMINE THAT THERE WAS NO INJURY REPORTED RELATED TO THIS ISSUE. HOWEVER CONSIDERING THE WORST CASE SCENARIO WHEN THE LOADS FALLING OFF THE TROLLEY COULD BRING A HAZARDOUS SITUATION FOR THE OPERATOR AND LEAD TO SERIOUS BODY INJURY IF THE SITUATION WAS TO REOCCUR, WE DECIDED TO REPORT THE COMPLAINT IN ABUNDANCE OF CAUTION. AFTER THE REPORTED EVENT, A GETINGE SERVICE TECHNICIAN VISITED THE CUSTOMER SITE, RESOLVED THE PROBLEM, REINSTALLED THE CART WHEEL ASSEMBLY AND RETURNED THE DEVICE FOR USAGE IN FULLY OPERATIONAL STAGE. TAKING INTO THE CONSIDERATION ALL INFORMATION AVAILABLE IT WAS DETERMINED BY THE SUBJECT MATTED EXPERT FROM THE MANUFACTURING SITE THAT THE FASTENERS CAME LOOSE AND THIS DIRECTLY LED TO THE REPORTED EVENT IN WHICH THE WHEEL DETACHED AND THE LOAD FELL. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE ACCESSORY USED WITH THE WASHER DISINFECTOR DID NOT MEET ITS SPECIFICATION AND IN THIS WAY DEVICE CONTRIBUTED TO REPORTABLE EVENT. THE GETINGE PRODUCT WAS DIRECTLY INVOLVED WITH THE REPORTED INCIDENT. HOWEVER, NONE OF THE PROVIDED INFORMATION INDICATES THAT UPON THE EVENT OCCURRENCE THE DEVICE WAS BEING USED FOR PATIENT TREATMENT. GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DO NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE NUMER: (B)(4).

    Description of Event or Problem · 0

    ON 27TH SEPTEMBER, 2021 GETINGE BECAME AWARE OF AN INCIDENT WHERE THE WHEEL BROKE OFF FROM AN INSTRUMENT WASH RACK WHICH IS AN ACCESSORY TO THE 9100 E SERIES WASHER DISINFECTOR. AS A CONSEQUENCE AT LEAST THREE TRAYS FELL TO FROM THE RACK TO THE FLOOR. THE INCIDENT OCCURRED WHILE THE UNIT WAS BEING OPERATED BY HOSPITAL STAFF DURING LOADING THE CART WASHER. THERE WAS NO INFORMATION PROVIDED ABOUT ADVERSE OUTCOME FOR THIS OCCURRENCE. THE INSTRUMENT WASH RACK IS NOT REGISTERED AS A MEDICAL DEVICE, HOWEVER UPON THE SITUATION OCCURRENCE IT WAS USED WITH THE MEDICAL DEVICE WASHER DISINFECTOR FROM 91E-SERIES AS A SYSTEM. INSTRUMENTS WHICH WAS FALLING OFF FROM THE TROLLEY COULD BRING A HAZARDOUS SITUATION FOR THE OPERATOR AND COULD POTENTIALLY LEAD TO SERIOUS BODY INJURY IF THE SITUATION WAS TO REOCCUR, THEREFORE WE DECIDED TO REPORT THE COMPLAINT IN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1474123 91E-SERIES DISINFECTOR, MEDICAL DEVICES MEC GETINGE DISINFECTION AB 9127E N/A 07340153710054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown