BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9100-SERIES

    MDR report key: 6510515 · Received April 21, 2017

    Report

    Report Number
    9616031-2017-00007
    Event Type
    Injury
    Date Received
    April 21, 2017
    Date of Event
    April 11, 2017
    Report Date
    April 27, 2018
    Manufacturer
    GETINGE DISINFECTION AB
    Product Code
    MEC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2016015 BY THE MANUFACTURER GETINGE DISINFECTION (B)(4). GETINGE RECEIVED A CUSTOMER COMPLAINT WITH INDICATION ABOUT SHARP EDGES FOUND ON THE WASH CART FOR 9100-SERIES WASHER DISINFECTOR WHICH WAS INDICATED TO HAVE CAUSED INJURY TO THE OPERATOR. 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). 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). THE EVENT IS BEING INVESTIGATED BY THE MANUFACTURING SITE. 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). THE EVENT IS BEING INVESTIGATED. ADDITIONAL INFORMATION WILL BE PROVIDED UPON RESULTS OF THE INVESTIGATION.

    Description of Event or Problem · 0

    ON 11TH APRIL 2017 WE WERE INFORMED BY (B)(4) REPRESENTATIVE ABOUT AN INCIDENT WHERE, AS STATED, THE OPERATOR HAS BEEN INJURED. DURING USING THE WASH CART FOR THE 9100-SERIES WASHER DISINFECTOR THE OPERATOR CUT HIS FINGER. THE INCIDENT WAS CAUSED BY THE SHARP EDGE LOCATED AT THE END RAIL OF THE WASH CART.

    Additional Manufacturer Narrative · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292615 9100-SERIES MEC MEC GETINGE DISINFECTION AB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other