BEUDAMED
    FDA Adverse Event Injury Summary report: N

    733HC

    MDR report key: 8189030 · Received December 21, 2018

    Report

    Report Number
    3012068831-2018-00013
    Event Type
    Injury
    Date Received
    December 21, 2018
    Date of Event
    November 21, 2018
    Report Date
    February 7, 2019
    Manufacturer
    GETINGE IC PRODUCTION POLAND SP. Z.O.O.
    Product Code
    FLE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2017051 BY THE MANUFACTURER GETINGE IC PRODUCTION POLAND SP. Z.O.O, (REGISTRATION NO. 3012068831) ON BEHALF OF THE IMPORTER GETINGE GROUP LOGISTICS AMERICA, LLC, (REGISTRATION NO. 3012092534). WHEN REVIEWING REPORTABLE EVENTS FOR THIS TYPE OF ISSUES WE WERE ABLE TO ESTABLISH THAT RECEIVED INCIDENT IS THE FIRST ONE REGISTERED IN GETINGE COMPLAINT HANDLING SYSTEMS FOR CARTS ISSUE ON 733HC DEVICE. THE ISSUE IS CONSIDERED TO BE SINGLE, ISOLATED EVENT. ON 26TH NOVEMBER, 2018 WE BECAME AWARE OF AN INCIDENT WITH ONE OF DEVICES-733HC. IT WAS STATED THAT TROLLEY USED WITH THIS PRODUCT DISLODGED FROM THE STERILIZER AND ROLLED BACK BEFORE THE CAR WAS FULLY UNLOADED. THE TECHNICIAN WHO OPERATED THIS DEVICE ATTEMPTED TO LIFT THE CAR BACK ONTO THE TROLLEY INJURED THE BACK. THE INJURY REQUIRED MEDICAL INTERVENTION. HAVING THIS IN MIND, WE DECIDED TO REPORT THIS COMPLAINT TO COMPETENT AUTHORITY. AFTER ISSUE OCCURRENCE, THE STUD THAT THE TROLLEY LOCK ON TO IN THE STERILIZER WAS REPLACED. TECHNICIAN TESTED THE TROLLEYS AND ENSURED THAT THEY LOCKED ONTO THE STUD AND STAY LOCKED WHILE PULLING ON THE TROLLEY. THE STERILIZER INVOLVED IN THE EVENT IS 733 HC STEAM STERILIZER, WITH SERIAL NUMBER (B)(4). DEVICE WAS MANUFACTURED ON 16TH JANUARY, 2007 AND INSTALLED ON (B)(6) 2007. THE COMPLAINT SUBJECT IS RELATED TO THE TROLLEYS USED WITH THE MENTIONED ABOVE STERILIZER. THEY ARE THE LOADING ACCESSORIES USED TO CARRY THE LOAD TO AND FROM STERILIZER. BASED ON THE INFORMATION COLLECTED TO DATE AND AS A RESULT OF PERFORMED INVESTIGATION IT HAS BEEN CONFIRMED THAT IF THE INSTRUCTIONS FOR USE WERE NOT FOLLOWED BY USER AND THAT RESULTED IN WRONG WAY OF LATCHING THE CARTS TO THE STERILIZER AND WRONG WORKING TECHNIQUE- INSTEAD OF UNLOADING THE CART BEFORE THE TECHNICIAN ATTEMPTED TO LIFT IT BACK UP ONTO THE TROLLEY, HE CHOSE TO ATTEMPT TO LIFT IT LOADED. THAT, IN CONSEQUENCE, HAS LED TO THE ADVERSE EVENT OCCURRENCE. ACCORDING TO THE USER MANUAL (USR 61301606344 REV B US, PAGE 4-24) USER IS PROPERLY INFORMED HOW TO LOAD THE STERILIZER. THE TRANSFER CARRIAGE SHOULD BE PULLED TO CHECK IF IT IS LOCKED SECURELY. IF IT IS DONE CORRECTLY, IT CANNOT BE PULLED AWAY FROM THE STERILIZER. IN SUMMARY, WHEN THE EVENT OCCURRED, THE DEVICE DID NOT MET ITS SPECIFICATION AND IT CONTRIBUTED TO EVENT. UPON THE EVENT OCCURRENCE THE DEVICE WAS NOT BEING USED FOR PATIENT TREATMENT. WE BELIEVE THAT IF THE MANUFACTURER RECOMMENDATION WOULD HAVE BEEN FOLLOWED THE INCIDENT COULD HAVE BEEN AVOIDED. GIVEN THE CIRCUMSTANCES AND THE FACT THAT THERE IS NO APPARENT TREND IN COMPLAINTS OF THIS NATURE WE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DO NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THE ISSUE IS BEING INVESTIGATED BY MANUFACTURING SITE. THIS REPORT IS BEING FILED UNDER EXEMPTION E2017051 BY THE MANUFACTURER GETINGE IC PRODUCTION POLAND SP. Z.O.O, (REGISTRATION NO. 3012068831) ON BEHALF OF THE IMPORTER GETINGE GROUP LOGISTICS AMERICA, LLC, (REGISTRATION NO. 3012092534).

    Additional Manufacturer Narrative · 0

    THE ISSUE IS BEING INVESTIGATED BY MANUFACTURING SITE. THIS REPORT IS BEING FILED UNDER EXEMPTION: E2017051 BY THE MANUFACTURER GETINGE IC PRODUCTION POLAND SP. Z.O.O, (REGISTRATION NO: (B)(4) ON BEHALF OF THE IMPORTER GETINGE GROUP LOGISTICS AMERICA, LLC, (REGISTRATION NO: (B)(4).

    Description of Event or Problem · 0

    ON (B)(4) 2018 WE BECAME AWARE OF AN INCIDENT WITH ONE OF DEVICES-733HC. IT WAS STATED THAT TROLLEY USED WITH THIS PRODUCT DISLODGED FROM THE STERILIZER AND ROLLED BACK BEFORE THE CAR WAS FULLY UNLOADED. THE TECHNICIAN WHO OPERATED THIS DEVICE ATTEMPTED TO LIFT THE CAR BACK ONTO THE TROLLEY INJURED THE BACK. THE INJURY REQUIRED MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027774 733HC 733HC FLE GETINGE IC PRODUCTION POLAND SP. Z.O.O.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention