BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9100-SERIES WASHER DISINFECTOR

    MDR report key: 6649307 · Received June 17, 2017

    Report

    Report Number
    9616031-2017-00019
    Event Type
    Malfunction
    Date Received
    June 17, 2017
    Date of Event
    May 18, 2017
    Report Date
    April 25, 2018
    Manufacturer
    GETINGE DISINFECTION AB
    Product Code
    MEC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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). GETINGE RECEIVED A CUSTOMER COMPLAINT WITH INDICATION ABOUT SHARP EDGES FOUND ON THE WASH CART FOR 9100-SERIES WASHER DISINFECTOR WHICH COULD CAUSE POTENTIAL INJURY TO THE OPERATOR. THERE WAS NO ADVERSE OUTCOME, HOWEVER WE DECIDED TO REPORT THIS TO COMPETENT AUTHORITIES BASED ON THE POTENTIAL AND IN ABUNDANCE OF CAUTION. PLEASE NOTE THAT WASH CART ITSELF IS AN ACCESSORY AND IT IS NOT REGISTERED AS MEDICAL DEVICE, HOWEVER WASHER DISINFECTOR IS REGISTERED AS MEDICAL DEVICE. THE ISSUE HAS BEEN INVESTIGATED FURTHER . IT HAS BEEN ESTABLISHED THAT THE WASH CARTS ARE BEING SUPPLIED BY AN EXTERNAL COMPANY AND THE ROOT CAUSE OF THE FAILURE IS CONNECTED WITH FINAL CHECK FOR SHARP EDGES ON THE CARTS. AS A RESULT OF RECEIVED COMPLAINTS GETINGE DECIDED TO INCREASE THE FINAL INSPECTION SO 100% OF THE PRODUCTS ARE BEING CHECKED FOR SHARP EDGES AT THE MANUFACTURING SITE, BEFORE BEING DISPATCHED TO THE FINAL CUSTOMER. 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.

    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 CARTS 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. NO INJURY HAS BEEN REPORTED . PER INFORMATION PROVIDED BY THE CUSTOMER HE HAS RECEIVED 6 WASH CARTS WITH THE SAME DEFECT. AS A RESULT IN WE REPORT THESE SIX COMPLAINTS SEPARATELY IN ABUNDANCE OF CAUTION. THIS IS REPORT FIVE FOR SIX.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2016015 BY (B)(4). THE EVENT IS BEING INVESTIGATED BY THE MANUFACTURING SITE. ADDITIONAL INFORMATION WILL BE PROVIDED UPON RESULTS OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429953 9100-SERIES WASHER DISINFECTOR MEC MEC GETINGE DISINFECTION AB 00607

    Patients

    Seq Age Sex Outcome Treatment
    1 Other