BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGS

    MDR report key: 8377509 · Received February 28, 2019

    Report

    Report Number
    9616031-2019-00005
    Event Type
    Injury
    Date Received
    February 28, 2019
    Date of Event
    February 19, 2019
    Report Date
    May 17, 2019
    Manufacturer
    GETINGE DISINFECTION AB
    Product Code
    PEC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORTS IS BEING FILED UNDER EXEMPTION E2017050 BY THE MANUFACTURER GETINGE DISINFECTION AB (REGISTRATION NO. (B)(4) ON BEHALF OF THE IMPORTER (B)(6) (REGISTRATION NO. (B)(4). THE ISSUE IS BEING INVESTIGATED BY MANUFACTURING SITE.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    AS EXPLAINED BY THE CUSTOMER, THE CART WAS STUCK ON AGS UNLOADING HOOK. THE CUSTOMER DECIDED TO REPOSITION THE CART MANUALLY WITHOUT ACTIVATING THE EMERGENCY STOP FIRST. CONSEQUENTLY, AFTER AMENDING THE CART, IT MOVED FORWARD AND LACERATED THE OPERATOR¿S HAND. WHEN REVIEWING REPORTABLE EVENTS, WE WERE ABLE TO ESTABLISH THAT THIS ISSUE IS A 4TH ONE OF THIS KIND. THE GETINGE AGS LOADING EQUIPMENT IS NOT REGISTERED AS A MEDICAL DEVICE ITSELF BUT SINCE UPON ISSUE OCCURRENCE, IT WAS USED TOGETHER WITH 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 (B)(6) 2007 AND INSTALLED ON (B)(6) 2007. THE WASHER SERIAL NUMBER THE LOADING EQUIPMENT WAS USED WITH HAS NOT BEEN PROVIDED. AFTER INCIDENT OCCURRED, THE ACCESSORY HAS BEEN INSPECTED BY GETINGE TECHNICIAN. THE DEVICE WAS FOUND TO BE FULLY FUNCTIONAL AND RETURNED FOR CUSTOMER¿S USAGE. THE ISSUE WAS INVESTIGATED BY MANUFACTURING SITE. IT WAS STATED THAT IT IS POSSIBLE THAT CART GETS JAMMED ON AGS DUE TO THE DIFFERENT REASONS E.G. LOADING TO SHUTTLE, WASHER GETTING STUCK OR LOADING TECHNIQUE. THE USER, WHO OPERATED THE DEVICE WHILE AN ISSUE OCCURRED, WAS CONFIRMED TO BE TRAINED BY MANAGER ON CUSTOMER SITE REGARDING SAFETY REQUIREMENTS. BASED ON PERFORMED INVESTIGATION, IT HAS BEEN DEFINED THAT A LIKELIHOOD OF CUSTOMER STAFF TO BE INJURED WHEN CARTS ARE JAMMING IS RELATED TO A COMBINATION OF SEVERAL FACTORS: USER¿S WRONG WORKING TECHNIQUE AND LACK OF DETAILED INSTRUCTIONS OF HOW TO USE AN EMERGENCY STOP IN THE MANUAL PROVIDED WITH THIS PARTICULAR DEVICE (FORMER REVISION), NAMELY HOW TO SOLVE THE PROBLEM AND RETRIEVE A FULL FUNCTIONALITY OF THE ACCESSORY. IN SUMMARY, WHEN THE EVENT OCCURRED, THE DEVICE DID NOT MEET ITS SPECIFICATION AND IT CONTRIBUTED TO THE ADVERSE EVENT. IN THE TIME WHEN THE EVENT OCCURRED, THE ACCESSORY WAS NOT BEING USED FOR PATIENT TREATMENT. GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DOES NOT PROPOSE ANY OTHER ACTION AT THIS TIME. THIS REPORTS IS BEING FILED UNDER EXEMPTION E2017050 BY THE MANUFACTURER GETINGE DISINFECTION AB (REGISTRATION NO. 9616031) ON BEHALF OF THE IMPORTER GETINGE GROUP LOGISTIC AMERICA, LLC (REGISTRATION NO. 3012092534).

    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.

    Description of Event or Problem · 0

    MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER'S REFERENCE NUMBER: TW241270.

    Description of Event or Problem · 0

    MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    ON (B)(4) 2019 WE BECAME AWARE OF AN INCIDENT WITH LOADING EQUIPMENT DEVICE ¿ AGS (AIR GLIDE SYSTEM) USED TOGETHER WITH WASHER DISINFECTOR AS IT WAS STATED, STAFF MEMBER WENT TO CLEAR A JAMMED CART ON AGS UNLOADING ARM. THE ARM CAME BACK RAPIDLY AND INJURED HIS THUMB. THE INJURY SUSTAINED WAS CLASSIFIED AS SERIOUS ONE (LACERATION ON THUMB REQUIRING STITCHES). ALTHOUGH THE AGS DEVICE IS NOT REGISTERED AS MEDICAL DEVICE, WHEN THE EVENT OCCURRED IT WAS BEING USED WITH A MEDICAL DEVICE AS A SYSTEM, THEREFORE WE DECIDED TO REPORT THIS ISSUE TO COMPETENT AUTHORITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173068 AGS STERILIZER AUTOMATED LOADING SYSTEM PEC GETINGE DISINFECTION AB

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention