BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    91E-SERIES

    MDR report key: 11998080 · Received June 15, 2021

    Report

    Report Number
    9616031-2021-00013
    Event Type
    Malfunction
    Date Received
    June 15, 2021
    Date of Event
    May 18, 2021
    Report Date
    August 30, 2021
    Manufacturer
    GETINGE DISINFECTION AB
    Product Code
    MEC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ON 18TH MAY, 2021 GETINGE BECAME AWARE OF AN ISSUE RELATED TO RAMP USED TOGETHER WITH 91E-SERIES WASHER DISINFECTOR WITH THE SERIAL NUMBER (B)(6) AND UDI NUMBER (B)(4) MANUFACTURED ON 30TH NOVEMBER, 2018. THE DEVICE WAS INSTALLED IN THE FACILITY ON MAY 10TH, 2019. THE DEVICE WAS UNDER GETINGE AGREEMENT AND THE LAST PREVENTIVE MAINTENANCE WAS PERFORMED ON 6TH APRIL, 2021. AS IT WAS STATED, THE CUSTOMER WAS PUSHING LOAD INTO THE CART WASH AND RAMP FELL CAUSING PERSON TO FALL. THE RAMP WAS AFFECTED AS THE TILT TAB BROKE ON LEFT SIDE CAUSING RAMP TO LOWER IN AN UNINTENDED WAY. WHEN REVIEWING REPORTABLE EVENTS FOR THIS TYPE WE FOUND THAT THIS IS THE SINGLE AND FIRST WHERE OPERATOR FELL DUE TO AFFECTED RAMP. UPON THE PERFORMED INVESTIGATION, GETINGE ESTABLISHED THAT THE MOST PROBABLE ROOT CAUSE OF THE EVENT REPORTED WAS RELATED TO THE UNAUTHORIZED INSTALLATION AS THE MOUNTED RAMP TYPE IS NOT COMPATIBLE AND NOT VALIDATED WITH THE 91E - SERIES OF THE WASHER DISINFECTORS. WITH THE INFORMATION RECEIVED TO DATE, IT REMAINS UNKNOWN HOW PERFORMED THE INSTALLATION OF THIS PART. WE CONFIRMED THAT THE RAMP WAS NOT PART OF THE ORDER PLACED FOR THIS PARTICULAR CUSTOMER. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE AFFECTED DEVICE HAS NOT PERFORMED AS INTENDED AND IT DIRECTLY CONTRIBUTED TO THE REPORTED EVENT. NONE OF THE PROVIDED INFORMATION INDICATES THAT UPON THE EVENT OCCURRENCE THE DEVICE WAS BEING USED FOR PATIENT TREATMENT. THE GETINGE PRODUCT WAS DIRECTLY INVOLVED WITH THE REPORTED INCIDENT.

    Description of Event or Problem · 0

    MANUFACTURE REFERENCE NUMBER (B)(4).

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2021 GETINGE BECAME AWARE OF AN ISSUE RELATED TO ONE OF THE WASHER-DISINFECTORS, 9125E. AS IT WAS STATED, THE LOAD RAMP TILT TAB BROKE ON LEFT SIDE CAUSING RAMP TO FALL. DUE TO THE ISSUE THE OPERATOR SUSTAINED THE MINOR INJURY TRYING TO LOAD THE DEVICE. FOR NOW WE DO NOT HAVE AN INFORMATION WHAT KIND OF INJURY WAS IT AND HOW IT HAPPENED, HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899358 91E-SERIES DISINFECTOR, MEDICAL DEVICES MEC GETINGE DISINFECTION AB 9125E

    Patients

    Seq Age Sex Outcome Treatment
    1