BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEXAVUE INTEGRATION SYSTEM

    MDR report key: 14161515 · Received April 20, 2022

    Report

    Report Number
    3008776287-2022-00003
    Event Type
    Malfunction
    Date Received
    April 20, 2022
    Date of Event
    March 25, 2022
    Report Date
    April 20, 2022
    Manufacturer
    STERIS CORPORATION
    Product Code
    KQM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE USER FACILITY CONTACTED STERIS AS THE HEXAVUE INTEGRATION SYSTEM WOULD NOT TURN ON. A STERIS SURGICAL REPRESENTATIVE THEN INSTRUCTED THE USER FACILITY TO UNPLUG THE HEXAVUE INTEGRATION SYSTEM FROM THE ISO PUCK AND PLUG IT DIRECTLY INTO THE WALL. FOLLOWING THE REPORTED EVENT, A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE HEXAVUE INTEGRATION SYSTEM AND FOUND THAT THE ISO PUCK REQUIRED REPLACEMENT. THE PURPOSE OF THE ISO PUCK IS TO DELIVER CLEAN AND CONSTANT POWER FROM THE WALL OUTLET TO THE HEXAVUE INTEGRATION SYSTEM, AND TO PREVENT CURRENT LEAKAGES OR SPIKES IN CURRENT. THE ISO PUCK SUBJECT OF THE EVENT WILL BE RETURNED TO STERIS FOR EVALUATION. THE USER FACILITY WILL BE PROVIDED WITH A REPLACEMENT ISO PUCK. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    CONTRARY TO INITIAL MRD, THE ISO PUCK SUBJECT OF THE EVENT WAS NOT EVALUATED BY STERIS FOR FURTHER INVESTIGATION. THE USER FACILITY HAS ELECTED TO CONTINUE USE OF THEIR HEXAVUE INTEGRATION SYSTEM WITHOUT A REPLACEMENT ISO PUCK. THE HEXAVUE INTEGRATION SYSTEM IS FULLY FUNCTIONAL WITHOUT AN ISO PUCK AS IT CAN BE PLUGGED DIRECTLY INTO THE WALL. THE DEVICE HISTORY RECORD WAS REVIEWED AND CONFIRMED THAT THE HEXAVUE INTEGRATION SYSTEM WAS MANUFACTURED ACCORDING TO SPECIFICATION. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THEIR HEXAVUE INTEGRATION SYSTEM WOULD NOT TURN ON. THERE WAS A PROCEDURE DELAY AS USER FACILITY PERSONNEL CONNECTED THE HEXAVUE INTEGRATION SYSTEM DIRECTLY INTO THE WALL OUTLET TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1271430 HEXAVUE INTEGRATION SYSTEM INTEGRATION SYSTEM KQM STERIS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown