BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    433HC

    MDR report key: 8023278 · Received October 31, 2018

    Report

    Report Number
    3012068831-2018-00012
    Event Type
    Malfunction
    Date Received
    October 31, 2018
    Date of Event
    October 10, 2018
    Report Date
    December 21, 2018
    Manufacturer
    GETINGE IC PRODUCTION POLAND SP. Z.O.O.
    Product Code
    FLE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2017051 BY THE MANUFACTURER GETINGE IC PRODUCTION POLAND SP. Z.O.O, (REGISTRATION NO. 3012068831) ON BEHALF OF THE IMPORTER GETINGE GROUP LOGISTICS AMERICA, LLC, (REGISTRATION NO. 3012092534). THE ISSUE IS BEING INVESTIGATED BY MANUFACTURING SITE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2017051 BY THE MANUFACTURER (B)(4). THE ISSUE IS STILLBEING INVESTIGATED BY MANUFACTURING SITE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2017051 BY THE MANUFACTURER GETINGE IC PRODUCTION POLAND SP. Z.O.O, (REGISTRATION NO. (B)(4)) ON BEHALF OF THE IMPORTER GETINGE GROUP LOGISTICS AMERICA, LLC, (REGISTRATION NO. (B)(4)). WHEN REVIEWING SIMILAR REPORTABLE EVENTS FOR 400-SERIES HEALTH CARE STEAM STERILIZERS WE HAVE BEEN ABLE TO DEFINE THAT THIS IS THE FIRST COMPLAINT RECEIVED ON UNEXPECTED STEAM LEAK FROM THE DEVICE ON PART ACCESSIBLE FOR THE USER. THERE IS NO TREND OBSERVED FOR THIS FAILURE MODE. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE DEVICE DID NOT MEET ITS SPECIFICATION AND IT CONTRIBUTED TO EVENT, YET IT WAS NOT USED FOR THE PATIENT TREATMENT OR DIAGNOSIS. THE DEVICE INVOLVED IN THE EVENT IS 400-SERIES HEALTH CARE STEAM STERILIZER WITH SERIAL NUMBER (B)(4) AND MODEL NUMBER 433HC. MANUFACTURING DATE OF THE DEVICE IS 3RD SEPTEMBER 2009. THE INSTALLATION DATE OF THE DEVICE IS 1ST FEBRUARY, 2010, WHICH GIVES US INFORMATION THAT DEVICE WAS IN USE FOR OVER 8 YEARS BEFORE THE EVENT OCCURRED. FOR THE COMPLAINT AT HAND, WE WERE NOT INFORMED ABOUT ANY INJURIES SUSTAINED, HOWEVER WE DECIDED TO REPORT THIS COMPLAINT TO COMPETENT AUTHORITIES BASED ON THE POTENTIAL AND IN ABUNDANCE OF CAUTION AS AN UNEXPECTED STEAM OR HOT WATER LEAK FROM PARTS AVAILABLE TO THE USER MAY LEAD TO AN ADVERSE OUTCOME. BASED ON THE PERFORMED EVALUATION WE CAN CONCLUDE THAT THE ISSUE OCCURRED DUE TO COMBINATION OF TWO FACTORS: THE DOOR WAS NOT SEALED PROPERLY AND THE DOOR SWITCH WAS STUCK. WE BELIEVE THAT ALL REMAINING DEVICES ARE PERFORMING CORRECTLY IN THE MARKET. WE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DO NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.

    Description of Event or Problem · 0

    ON (B)(6) 2018 WE BECAME AWARE OF AN INCIDENT WITH ONE OF STEAM STERILIZERS- 433HC. AS STATED BY THE CUSTOMER, THE DOOR GASKET POPPED OUT AND STEAM AND WATER SPIT ON USER. THERE IS NO INJURY REPORTED. TO DATE WE DID NOT RECEIVE ANY INFORMATION ABOUT THE WATER AND STEAM TEMPERATURE HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS AN UNEXPECTED HOT STEAM OR WATER LEAK MAY LEAD TO ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863207 433HC 433HC FLE GETINGE IC PRODUCTION POLAND SP. Z.O.O.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other