BEUDAMED
    FDA Adverse Event Summary report: N

    PREVAC

    MDR report key: 2250660 · Received September 7, 2011

    Report

    Report Number
    2250660
    Date Received
    September 7, 2011
    Date of Event
    August 18, 2011
    Report Date
    September 7, 2011
    Manufacturer
    STERIS CORPORATION
    Product Code
    FLE
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    WE RECIEVED A CALL FROM OUR ENDOSCOPY DEPARTMENT INDICATING THERE WAS AN ERROR RELAY 2 FAILURE ON THEIR STEAM STERILZER. OUR BIOMEDICAL TECHNICIAN INSPECTED THE STERILZER AND PROCEEDED TO CALL BOTH STERIS AND OUR 3RD PARTY SERVICE PROVIDER. BOTH RESOURCES INDICATED TO REPLACE SOME CIRCUIT BOARDS (I/O BOARD AND CONTROL BOARD). OUR TECHNICIAN WORKED EXTENSIVELY ON TRYING TO LOCATE THE PROBLEM. AFTER SPENDING A DAY ON THE REPAIR, WE MADE A DECISION FOR STERIS REPRESENTATIVE TO COME IN THE NEXT DAY TO REPAIR. WHEN THE TECHNICIAN CAME IN, HE WAS GOING THROUGH HIS INITIAL INSPECTIONS. AFTER ABOUT AN HOUR INTO THE INSPECTION, ONE OF THE ENDO NURSING STAFF CAME INTO THE ROOM AND THE DOOR ACTUALLY HIT THE EMERGENCY STOP BUTTON THAT IS LOCATED ON THE FRONT OF THE STERILIZER DOOR. THE TECHNICIAN WAS ABLE TO RESET THE EMERGENCY STOP AND TEST THE STERLIZER. THE STERLIZER WAS WORKING FINE AND NO FURTHER REPAIRS WERE NEEDED. APPARENTLY THIS VERSION OF STERLIZER HAS THIS EMERGENCY STOP BUTTON ADDED. WHAT WAS FRUSTRATING, IS BOTH THE MANUFACTURER AND THE 3RD PARTY VENDOR DID NOT FIRST ASK IF THIS EMERGENCY BUTTON WAS PRESSED. WE HAVE SINCED WORKED WITH THE STAFF TO BE AWARE IF THE EMERGENCY BUTTON IS ACCIDENTLY PRESSED WHEN THE DOOR TO THIS ROOM IS OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREVAC STERILIZER, STEAM FLE STERIS CORPORATION V116 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *