BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    88-SERIES

    MDR report key: 6933788 · Received October 10, 2017

    Report

    Report Number
    9616031-2017-00030
    Event Type
    Malfunction
    Date Received
    October 10, 2017
    Date of Event
    September 12, 2017
    Report Date
    May 24, 2018
    Manufacturer
    GETINGE DISINFECTION AB
    Product Code
    MEC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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). THE EVENT IS BEING INVESTIGATED. 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). ADDITIONAL INFORMATION WILL BE PROVIDED UPON RESULTS OF THE INVESTIGATION.

    Description of Event or Problem · 0

    ON (B)(6) GETINGE BECAME AWARE OF A SHARP EDGES FOUND BY THE CUSTOMER ON THE WASH CART USED FOR LOADING THE PRODUCTS INTO THE WASHER-DISINFECTORS. PLEASE NOTE THAT WASH CART IS NOT A MEDICAL DEVICE ITSELF HOWEVER IT IS AN ACCESSORY TO WASHER DISINFECTOR WHICH IS REGISTERED AS MEDICAL DEVICE. PER INFORMATION PROVIDED BY THE CUSTOMER WHEN CLEANING THE WASH CART THE OPERATOR GET HURT ON THE SHARP EDGE OF THE CART. WE DECIDED TO REPORT THIS CASE IN ABUNDANCE OF CAUTION.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2016015 BY THE MANUFACTURER GETINGE DISINFECTION (B)(4), (B)(4) GETINGE RECEIVED CUSTOMER COMPLAINT WITH INDICATION ABOUT SHARP EDGES FOUND ON THE WASH CART FOR 88-SERIES WASHER DISINFECTOR WHICH CAUSED INJURY TO THE OPERATOR WHO WAS CLEANING THE WASH CART. PLEASE NOTE THAT WASH CART ITSELF IS AN ACCESSORY AND IT IS NOT REGISTERED AS MEDICAL DEVICE, HOWEVER THE WASHER DISINFECTOR IT IS USED WITH IS REGISTERED AS MEDICAL DEVICE. THE ISSUE HAS BEEN INVESTIGATED FURTHER. IT HAS BEEN ESTABLISHED THAT THE ROOT CAUSE OF THE FAILURE IS CONNECTED WITH AN INCIDENTAL WRONG WELDING OF THE SHELVES OF THE WASH CART. IT HAS BEEN ESTABLISHED THAT THE ISSUE IS A SINGLE, ISOLATED EVENT LIMITED TO ONE SPECIFIC WASH CART. IN SUMMARY, WHEN THE INCIDENT OCCURRED THE DEVICE WAS NOT BEING USED FOR THE PATIENT TREATMENT OR DIAGNOSIS, HOWEVER IT PLAYED A ROLE IN IT. DURING THE INVESTIGATION IT HAS BEEN CONFIRMED THAT THE DEVICE FAILED TO MEET IT SPECIFICATION AND DIRECTLY LED TO THE EVENT. GIVEN THE CIRCUMSTANCES AND THE FACT THAT THERE IS NO TREND OBSERVED FOR CUSTOMER COMPLAINTS WITH THIS FAILURE MODE, WE SHALL CONTINUE TO MONITOR FURTHER EVENTS OF THIS NATURE AND DO NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718676 88-SERIES MEC MEC GETINGE DISINFECTION AB 88-5

    Patients

    Seq Age Sex Outcome Treatment
    1 Other