BEUDAMED
    FDA Adverse Event Other Summary report: N

    48" CENTURY DOMESTIC HINGE

    MDR report key: 1047867 · Received May 8, 2008

    Report

    Report Number
    2515984-2008-00009
    Event Type
    Other
    Date Received
    May 8, 2008
    Date of Event
    April 8, 2008
    Report Date
    May 6, 2008
    Manufacturer
    STERIS MEXICO S. DE R. L. DE C.V.
    Product Code
    FLE
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING ENGINEER ASSIGNED TO THE FAILURE INVESTIGATION, RULED OUT THAT THE DRAIN VALVE FAILURE. TWO ADDITIONAL COMPONENTS: THE STREAM TRAP (TR1) AND THE DRAIN SOLENOID VALVE (S40), MUST BOTH FAIL AT THE SAME TIME TO ACCUMULATE WATER IN THE CHAMBER. THEREFORE, THIS ISSUE IS LIKELY OPERATOR MISUSE. THE MANUAL OPERATOR (B) (4) CONTAINS THE WARNING SECTION (PAGE 1-2) THAT"...STEAM MAY BE RELEASED FROM THE CHAMBER WHEN DOOR IS OPENED TO MINIMIZE CONTACT WITH STEAM VAPOR". ADDITIONALLY, THE OPERATIVE INSTRUCTIONS (REF. MANUAL OPERATOR SECTION (B) (4) "DOOR UNSEALED) MAKES MENTION THE OPERATOR SHALL SILENCE THE ALARM AND CALL SERVICE.

    Description of Event or Problem · 1

    THE HOSPITAL BIOMEDICAL TECHNICIAN WAS INVESTIGATING A REPORTED PROBLEM OF DOOR UNSEALED ALARM. WHEN SHE OPENED THE DOOR, A BURST OF STEAM CAME OUT AND HIT HER IN THE FACE. SHE COULD NOT BACK AWAY FROM THE STEAM BECAUSE THE LOADING CARTS WERE IN FRONT OF THE STERILIZER RESTRICTING HER MOVEMENTS. THE DOOR WAS UNSEALED AT THE TIME BUT CLOSED. THE FIELD SERVICE TECHNICIAN REPORTED A DRAIN CHECK VALVE HAD FAILED OPEN CAUSING WATER TO BE PULLED BACK UP INTO THE CHAMBER AND BOILED INTO STEAM. INJURIES WERE FIRST DEGREE ON FACE, NOSE, EYES AND MOUTH. THE BIOMEDICAL TECHNICIAN WAS TREATED AT THE ER AT THE FACILITY AND RETURNED TO WORK AFTERWARDS (SHE DID NOT TAKE ANYTIME OF WORK). EVIDENCE OF WARNING LABELS: (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 48" CENTURY DOMESTIC HINGE STERILIZER FLE STERIS MEXICO S. DE R. L. DE C.V. 1102321 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention