BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GETINGE STEAM STERILIZER

    MDR report key: 2153338 · Received June 30, 2011

    Report

    Report Number
    1314329-2011-00003
    Event Type
    Injury
    Date Received
    June 30, 2011
    Date of Event
    May 19, 2011
    Report Date
    June 3, 2011
    Manufacturer
    GETINGE SOURCING LLC
    Product Code
    FLE
    PMA / PMN Number
    K020590
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    GETINGE REP WENT TO FACILITY AND INSPECTED THE STERILIZER INVOLVED IN THE INCIDENT. GETINGE REP REPORTED THAT THE FACILITY BIOMED HAD TIGHTENED LOOSE SCREWS HOLDING THE LOCKING POST TO THE INTERIOR BRACKET. USER MANUAL WAS REVIEWED - THE STEPS LISTED FOR REMOVING THE LOAD INDICATE A CHECK THAT THE CART IS SECURELY LOCKED BEFORE REMOVING THE RACK. IT IS NOT KNOWN IF THE OPERATOR PERFORMED THIS STEP PRIOR TO THE INCIDENT. THIS IS THE FIRST REPORT OF THE LOCKING NUT HARDWARE BECOMING LOOSE. FURTHER INVESTIGATION IS REQUIRED TO DETERMINE IF ANY ADDITIONAL ACTION IS NEEDED.

    Description of Event or Problem · 1

    USER FACILITY NOTIFIED GETINGE REP THAT AN INCIDENT HAD OCCURRED WITH THE 733HC STERILIZER DURING UNLOADING. THE LOAD CART WAS NOT PROPERLY ATTACHED TO THE LOCKING POST/TRACK ASSEMBLY LOCATED IN THE INTERIOR OF THE STERILIZER AND WHEN THE OPERATOR WENT TO PULL THE CART OUT, THE RACK BEGAN FALLING. THE OPERATOR CAUGHT THE RACK AND PUSHED IT BACK INTO THE STERILIZER. THE RACK TIPPED PINNING THE OPERATOR'S ARM BETWEEN THE RACK AND THE INTERIOR STERILIZER CHAMBER WALL. OPERATOR WAS SENT TO THE ER FOR TREATMENT TO BURNS ON HIS FOREARM. THE OPERATOR WAS TREATED AND RELEASED WITH 2ND DEGREE BURNS TO THE FOREARM. OPERATOR REPORTED BACK TO WORK WITH IN 2 DAYS. THE STERILIZER IS MAINTAINED BY THE FACILITY'S BIOMED. THE BIOMED REPORTED THAT THERE WERE LOOSE SCREWS FOUND ON THE BRACKET THAT HOLD THE LOCKING POST IN PLACE. SCREWS WERE TIGHTENED BY THE BIOMED AND NO FURTHER PROBLEMS HAVE BEEN NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GETINGE STEAM STERILIZER STEAM STERILIZER FLE GETINGE SOURCING LLC 733HC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention