BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8668

    MDR report key: 6632896 · Received June 11, 2017

    Report

    Report Number
    9616031-2017-00013
    Event Type
    Injury
    Date Received
    June 11, 2017
    Date of Event
    April 28, 2017
    Report Date
    September 18, 2017
    Manufacturer
    GETINGE DISINFECTION AB
    Product Code
    MEC
    Adverse Event
    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). WE ARE AWARE THAT FOR MFR. REF. NO. 9616031-2016-00013 INITIAL REPORT WE ARE PAST THE 30 DAY DEADLINE FOR REPORTING. IT WAS DUE TO THE HUMAN ERROR. 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). WE ARE AWARE THAT FOR MFR. REF. NO. 9616031-2016-00013 INITIAL REPORT WE ARE PAST THE 30 DAY DEADLINE FOR REPORTING. IT WAS DUE TO THE HUMAN ERROR. THE EVENT IS BEING INVESTIGATED. ADDITIONAL INFORMATION WILL BE PROVIDED UPON RESULTS OF THE INVESTIGATION.

    Description of Event or Problem · 0

    ON (B)(6) 2017 TECHNICIAN WHO ARRIVED AT CUSTOMER SITE BEGUN AN ADJUSTMENT OF THE UNLOADER. AS IT WAS DESCRIBED THE TECHNICIAN HAD FINGER CAUGHT BETWEEN UNLOADER ARM AND WASH RACK WHILE TRYING TO MANUALLY PUSH WASH RACK FROM WASHER CHAMBER. AS A RESULT THE TECHNICIAN CUT MIDDLE FINGER OF RIGHT HAND THAT REQUIRED STITCHES.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2016015 BY THE MANUFACTURER GETINGE DISINFECTION AB. WE ARE AWARE THAT FOR MFR. REF. NO. 9616031-2016-00013 INITIAL REPORT WE ARE PAST THE 30 DAY DEADLINE FOR REPORTING. IT WAS DUE TO THE HUMAN ERROR. GETINGE BECAME AWARE OF AN EVENT CAUSED BY A MALFUNCTIONING ACCESSORY TO THE MEDICAL DEVICE: AN UNLOADER. THE PURPOSE OF THE UNLOADER IS TO FACILITATE UNLOADING CARTS WITH MATERIALS FROM THE WASHER DISINFECTOR DEVICE. AS IT WAS STATED THE OPERATOR SUSTAINED AN INJURY DURING THE MANUAL UNLOADING OF THE CART FROM THIS UNLOADER. ALL INFORMATION PROVIDED BY THE CUSTOMER HAS BEEN REVIEWED. IT WAS ESTABLISHED THAT THE EVENT TOOK PLACE AS A RESULT OF A MALFUNCTION AT THE UNLOADER'S ARM. TRANSFER OF THE GOODS AFTER THE WASHING PROCESS IS PERFORMED BY ACTIVATION OF AUTOMATIC UNLOADER AND NORMALLY IT DOES NOT REQUIRE PRESENCE OF THE OPERATOR DURING THIS PROCESS. WHEN THERE IS NO ISSUE WITH THE UNLOADER THE UNLOADING ARM IS GRABBING THE WASH CART FROM THE WASHER DISINFECTOR AND IT PULLS IT ON THE TRANSFER ROLLS FROM WHERE IT COULD BE TRANSFERRED FURTHER. IN THE CASE AT HAND THE OPERATOR DECIDED TO UNLOAD THE WASH CART MANUALLY AS THE AUTOMATIC UNLOADING FAILED. DUE TO THE MISALIGNED HEIGHT OF THE UNLOADER THIS CAUSED THE ARM TO MISS GRABBING THE WASH RACK AND NOT PULL IT FULLY ON THE FIRST SET OF CONVEYOR BELT ROLLERS. WHEN THE OPERATOR TRIED TO MANUALLY PULL THE WASH RACK OUT OF THE WASHER THE UNLOADER ARM MOVED FORWARD AND CAUGHT OPERATOR'S FINGER BETWEEN WASH CART AND THE UNLOADING ARM. IT RESULTED IN INJURY WHICH REQUIRED MEDICAL INTERVENTION BY APPLYING SIX STICHES. WHEN THE EVENT TOOK PLACE THE ACCESSORY NOR THE WASHER DISINFECTOR DEVICE WAS NOT USED FOR TREATMENT OR DIAGNOSIS. DURING EACH PROCESS THE UNLOADING ARM IS CONSTANTLY MOVING, THEREFORE IT IS SUBJECT TO WEAR AND TEAR. IT IS IMPORTANT TO PERFORM A PERIODICAL INSPECTION OF THE DEVICE IN ORDER TO KEEP IT FUNCTIONAL. TECHNICAL MANUAL FOR GETINGE AGS (504254300, REV. B) STATES THAT UNLOADING ARM SHOULD BE CHECKED EVERY YEAR AND IF NECESSARY IT SHOULD BE REPLACED OR ADJUSTED. FROM INFORMATION PROVIDED SO FAR WE FOUND THAT THE DEVICE HAD BEEN INSTALLED 1,5 YEAR BEFORE THE INCIDENT OCCURRED AND NO DOCUMENTED PREVENTIVE MAINTENANCE PERFORMED DURING THIS TIME. THEREFORE WE CANNOT RULE OUT THAT A ROOT CAUSE OF THE INCIDENT IS A COMBINATION OF THE WEARING OF THE PART AND LACK OF THE MAINTENANCE PERFORMED BY THE USER. WE BELIEVE THAT IT THE USER WOULD HAVE FOLLOWED THE MANUFACTURER RECOMMENDATION THE INCIDENT WOULD HAVE BEEN AVOIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413598 8668 MEC MEC GETINGE DISINFECTION AB 8668

    Patients

    Seq Age Sex Outcome Treatment
    1 Other