BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GETINGE 833HC STEAM STERILIZER

    MDR report key: 3063690 · Received April 12, 2013

    Report

    Report Number
    1314329-2013-00001
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 15, 2013
    Manufacturer
    GETINGE SOURCING LLC
    Product Code
    FLE
    PMA / PMN Number
    K031259
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING THE INCIDENT, TWO GETINGE SERVICE REPS FOLLOWED UP TO INVESTIGATE. ARRIVED ON SITE AND FOUND STERILIZER PIT COMPLETELY FULL OF WATER DUE TO CLOGGED FACILITY DRAIN. FACILITY MAINTENANCE WAS CALLED TO CLEAR CLOGGED DRAIN AND ALLOW FURTHER INVESTIGATION. GETINGE REPS CHECKED WATER IN DRAIN (WID) SWITCH BY MANUALLY ACTUATING FLOAT SWITCH. WID ALARM WORKED NORMALLY - NO FAULT FOUND. FLOAT SWITCH WAS REPLACED AS A PRECAUTION (NOTE: FLOAT SWITCH WAS DAMAGED DURING REMOVAL AND COULD NOT BE FURTHER INVESTIGATED AS CONTRIBUTING CAUSE OF FAILURE). DRAIN VALVE DISASSEMBLED AND INSPECTED. WATER TO EJECTOR TURNED ON CAUSING WATER FLOW FROM VALVE BODY. EJECTOR PIPING DISASSEMBLED AND INSPECTED. DEBRIS FOUND IN EXIT END OF EJECTOR CAUSING BLOCKAGE THAT FORCED WATER BACK UP DRAIN PIPING TO DRAIN VALVE. DEBRIS WAS IDENTIFIED AS DAMAGED PLUNGER FROM JACKET TRAP CHECK VALVE. DEBRIS CLEARED AND EJECTOR FUNCTIONS NORMALLY. REPS REPLACED MULTIPLE VALVES FOUND TO BE IN NEED OF REPLACEMENT. CONTRIBUTING FAILURES INCLUDE; CLOGGED FACILITY DRAIN, MULTIPLE WORN VALVES AND POSSIBLE INTERMITTENT FAILURE OF FLOAT SWITCH. STERILIZER WAS REPAIRED AND VERIFIED TO FUNCTION TO SPECIFICATION INCLUDING VERIFICATION OF THE WATER IN DRAIN ALARM. STERILIZER WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    CUSTOMER CALLED FOR WATER IN DRAIN ALARM. DOOR WAS CLOSED AND SEALED. UNIT HAD GONE TO 45 PSI SO STEAM WAS SHUT OFF. GETINGE SERVICE REP ARRIVED AND ATTEMPTED TO CLEAR WATER FROM DRAIN. STERILIZER PIT HAD 1/2 INCH OF WATER IN IT. REP OPENED CHAMBER DRAIN BALL VALVE FULLY. REP CHECKED CHAMBER PRESSURE AND SEEING NO CHANGE WENT BACK AND CLOSED THE BALL VALVE. REP LOOSENED UNIONS AROUND STEAM TO CHAMBER VALVE TO RELIEVE PRESSURE. CHAMBER PRESSURE DROPPED TO 0 PSI. REP FOUND SUSPECT STEAM TO CHAMBER VALVE AND REPLACED. REP TURNED UNIT BACK ON AND HAD WATER IN DRAIN ALARM. REP SILENCED ALARM AND ALARM CLEARED INCLUDING TEXT MESSAGE ON SCREEN. REP TURNED STEAM ON TO UNIT. REP PRESSED DOOR UNSEAL SOFT KEY AND DOOR UNSEALED WITHOUT INCIDENT. REP PRESSED DOOR OPEN. WHEN DOOR OPENED WATER FLOWED OUT OF CHAMBER AND ACROSS THE FLOOR. WATER WAS HOT ENOUGH TO CAUSE MINOR BURNS TO REP'S ANKLES AND 2ND DEGREE BURNS TO THE BOTTOM OF A HOSPITAL EMPLOYEE'S (INSTRUMENT PROCESSOR) FEET WHO WAS STANDING IN ROOM AT TIME OF INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157430 GETINGE 833HC STEAM STERILIZER STEAM STERILIZER FLE GETINGE SOURCING LLC 833HC

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention