BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGS

    MDR report key: 8189031 · Received December 21, 2018

    Report

    Report Number
    9616931-2018-00011
    Event Type
    Malfunction
    Date Received
    December 21, 2018
    Date of Event
    December 5, 2018
    Report Date
    February 11, 2019
    Manufacturer
    GETINGE DISINFECTION AB
    Product Code
    PEC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2017050 BY THE MANUFACTURER GETINGE DISINFECTION AB, (REGISTRATION NO. 9616031) ON BEHALF OF THE IMPORTER GETINGE GROUP LOGISTICS AMERICA, LLC (REGISTRATION NO. 3012092534). THE ISSUE IS BEING INVESTIGATED BY MANUFACTURING SITE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2017050 BY THE MANUFACTURER GETINGE DISINFECTION AB, (REGISTRATION NO. (B)(4)) ON BEHALF OF THE IMPORTER GETINGE GROUP LOGISTICS AMERICA, LLC (REGISTRATION NO. (B)(4)). WHEN REVIEWING REPORTABLE EVENTS, WE WERE ABLE TO ESTABLISH THAT THIS ISSUE IS A SECOND ONE WHERE AN INJURY WAS SUSTAINED BY AN OPERATOR, DURING THE ATTEMPT OF CORRECTING THE CART POSITION ON THE AIR GLIDE SYSTEM (AGS) LOADING SYSTEM. THE GETINGE AGS LOADING EQUIPMENT IS NOT REGISTERED AS A MEDICAL DEVICE ITSELF BUT SINCE UPON ISSUE OCCURRENCE, IT WAS USED TOGETHER WITH A 8668 WASHER-DISINFECTOR, WE DECIDED TO REPORT THE COMPLAINT TO COMPETENT AUTHORITIES IN REGARD TO THE SYSTEM. THE SERIAL NUMBER OF THE ACCESSORY WAS (B)(4). THE UNIT WAS MANUFACTURED ON 15TH DECEMBER, 2006 AND INSTALLED ON (B)(6) 2007. THE WASHER SERIAL NUMBER THE LOADING EQUIPMENT WAS USED WITH HAS NOT BEEN PROVIDED. AS EXPLAINED BY THE CUSTOMER, THE CART DID NOT ENGAGE IN THE AGS AND THE ARM THAT PUSHES BASKET ON LOADING SIDE GOT STUCK. THE CUSTOMER DECIDED TO REPOSITION THE CART MANUALLY WITHOUT ACTIVATING THE EMERGENCY STOP FIRST. CONSEQUENTLY, AFTER AMENDING THE CART, IT MOVED FORWARD AND PINCHED OPERATOR'S FINGER. THE AGS SYSTEM IS EQUIPPED IN AN EMERGENCY STOP LOCATED IN THE ELECTRICAL CABINET ON THE RIGHT SIDE OF THE CONVEYORS AND ON THE RIGHT SIDE OF THE SHUTTLE. THERE ARE A NUMBER OF EMERGENCY STOPS ON THE AGS UNIT DEPENDING ON HOW IT IS CONFIGURED. WHEN THE EMERGENCY STOP IS ACTIVATED, ALL MOVING PARTS OF THE MACHINE ARE DISCONNECTED FROM THE POWER SUPPLY. REGARDLESS OF WHICH SIDE THE EMERGENCY STOP IS ACTIVATED FROM, THE ENTIRE AGS UNIT IS HALTED. THIS INSTRUCTION IS BEING DESCRIBED IN USER MANUAL (DOCUMENT # (B)(4)) CLEARLY STATES THAT EMERGENCY STOP IS TO BE ACTIVATED WHEN SOMEONE ENTERS THE MACHINE'S WORKING AREA. AFTER THE INCIDENT OCCURRED, THE ACCESSORY HAS BEEN INSPECTED BY GETINGE TECHNICIAN. IT WAS STATED THAT FOLLOWING PARTS WERE REPLACED AS THEY WERE WORN DUE TO NORMAL WEAR: 1-1/4"PUSH ARM, 4"PUSH ARM AND SPRING ASSEMBLY. NONE OF THE INFORMATION AVAILABLE TO DATE SUGGEST THAT THE REPLACEMENT OF THOSE PARTS WAS DIRECTLY RELATED WITH THE REPORTED INCIDENT. ADDITIONALLY IT WAS FOUND THAT C-CLIPS FOR BOTH LOADING AND UNLOADING SIDE WERE MISSING AND PINS WERE HELD WITH WIRES. AFTER THE REPLACEMENT, THE DEVICE WAS CHECKED, FOUND TO BE FULLY FUNCTIONAL AND RETURNED FOR CUSTOMER'S USAGE. IN SUMMARY, WHEN THE EVENT OCCURRED, THE DEVICE DID NOT MEET ITS SPECIFICATION - BUT ONLY DUE TO SOME PARTS HAVING BEEN FOUND WORN, AND THIS WEAR IS NOT CONSIDERED RELATED TO THE EVENT . THE REPORTED INCIDENT RESULTED FROM USER NOT FOLLOWING USE INSTRUCTIONS AND THIS CONTRIBUTED TO THE EVENT. IN THE TIME WHEN THE EVENT OCCURRED, THE ACCESSORY WAS NOT BEING USED FOR PATIENT TREATMENT. GIVEN THE FINDINGS OF THIS INVESTIGATION GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DOES NOT PROPOSE ANY OTHER ACTION AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2017050 BY THE MANUFACTURER GETINGE DISINFECTION AB, (REGISTRATION NO. (B)(4)) ON BEHALF OF THE IMPORTER GETINGE GROUP LOGISTICS AMERICA, LLC (REGISTRATION NO. (B)(4)). THE ISSUE IS BEING INVESTIGATED BY MANUFACTURING SITE. ACCORDING TO NEW INFORMATION PROVIDED, THE USER DID NOT SUSTAIN A SERIOUS INJURY.

    Description of Event or Problem · 0

    ON (B)(4) 2018 GETINGE DISINFECTION (B)(4) BECAME AWARE OF AN INCIDENT WITH ONE OF DEVICES- AGS. AS STATED BY CUSTOMER, THE ARM THAT PUSHES BASKET ON LOADING SIDE GOT STUCK AND REQUIRED MANUAL INTERVENTION. IT CAUSED AN INJURY OF AN EMPLOYEE WHOSE ARM WAS CAUGHT UNDER THE CART. AFTER THE INCIDENT, THE EMPLOYEE WENT INTO ER FOR TREATMENT PURPOSE. AGS IS A SUPPLEMENTAL PRODUCT TO THE WASHER DISINFECTOR REGISTERED AS THE MEDICAL DEVICE AND WE DECIDED TO REPORT INCIDENT RESULTED IN SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027775 AGS AGS PEC GETINGE DISINFECTION AB

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention