BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    91-SERIES

    MDR report key: 11669998 · Received April 15, 2021

    Report

    Report Number
    9616031-2021-00009
    Event Type
    Malfunction
    Date Received
    April 15, 2021
    Date of Event
    April 9, 2021
    Report Date
    June 10, 2021
    Manufacturer
    GETINGE DISINFECTION AB
    Product Code
    MEC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    GETINGE BECAME AWARE ON 12TH APRIL, 2021 ABOUT AN EVENT WITH A WASHER DISINFECTOR FROM 91-SERIES THAT TOOK PLACE ON (B)(6) 2021. THE INVOLVED DEVICE WAS IDENTIFIED TO CARRY SERIAL NUMBER: (B)(6) AND CATALOG NUMBER: 9128-CTOM. MANUFACTURE DATE OF THE DEVICE IS 14TH OCTOBER, 2010. THE MENTIONED UNIT IS UNDER GETINGE MAINTENANCE AND AS IT WAS CONFIRMED THE LAST SERVICE WAS CARRIED OUT BETWEEN 23RD AND 25TH MARCH 2021. WE ESTABLISHED THAT STEAM GUSHED OUT FROM THE WASHER AND DIRECTLY CONTRIBUTED TO THE ADVERSE EVENT. BASED ON THAT INITIAL INFORMATION THERE WAS A RISK OF SKIN BURN AND THEREFORE WE DECIDED TO REPORT THE CASE IN ABUNDANCE OF CAUTION AS THIS KIND OF MALFUNCTION COULD LEAD TO SERIOUS INJURY. AS A RESULT OF PERFORMED INVESTIGATION WE COULD ESTABLISH THAT THE MOST PROBABLE ROOT CAUSE WAS CAUSED BY FILTER CLAMP STRAP WHICH WAS DEFORMED AFTER 11 YEARS OF USAGE AND IT WAS NOT ATTACHED. IT DIRECTLY LED TO THE GAP BETWEEN HEPA-FILTER AND HEATER BOX WHICH CAUSED THAT THE HEAT WAS NOT SUCKED FROM THE CHAMBER AND CUMULATED STEAM GUSHED OUT WHILE THE DOOR WAS OPENED AFTER THE CYCLE WAS COMPLETED. THE PROBLEM HAS BEEN RESOLVED BY THE REPLACEMENT OF FILTER CLAMP STRAP AND THE UNIT IS WORKING IN FULLY OPERATIONAL STATE. AFTER THE INVESTIGATION COURSE WE WERE ALSO ABLE TO CONFIRMED THAT THIS IS THE FIRST ISSUE CONNECTED WITH THIS TYPE OF MALFUNCTION. WHEN THE EVENT OCCURRED, THE DEVICE WAS DIRECTLY INVOLVED AND DID NOT MEET ITS SPECIFICATION SINCE THE STEAM LEAKED OUT AND IT CONTRIBUTED TO THE EVENT. UPON THE EVENT OCCURRENCE THE DEVICE WAS NOT BEING USED FOR PATIENT TREATMENT. WHEN REVIEWING SIMILAR REPORTABLE EVENTS FOR THE SAME DEVICE TYPE, WE HAVE BEEN ABLE TO CONFIRM THAT THE INVESTIGATED ISSUE HAS NEVER LED TO SERIOUS INJURY OR WORSE, TO OUR KNOWLEDGE. WE CURRENTLY DO NOT HAVE ANY INFORMATION THAT WOULD WARRANT FURTHER ACTION TOWARDS THE DEVICE MANUFACTURING OR DEVICES ON THE MARKET, HOWEVER GETINGE WILL CONTINUE TO MONITOR THE CUSTOMER EXPERIENCES WITH THE DEVICE FOR ANY FUTURE INFORMATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    ON 12TH APRIL, 2021 GETINGE BECAME AWARE ABOUT AN ISSUE WITH ONE OF THE DEVICES ¿ 9128 WASHER DISINFECTOR WHICH TOOK PLACE ON (B)(6) 2021. AS IT WAS STATED WHEN THE OPERATOR OPENED THE DOOR OF THE WASHER DISINFECTOR THE STEAM GUSHED OUT. THE RELEASED STEAM LED TO ACTIVATING THE FIRE ALARM AND THE BUILDING WAS EVACUATED. THERE WAS NO INJURY REPORTED, HOWEVER WE DECIDED TO REPORT THE COMPLAINT TO THE COMPETENT AUTHORITIES IN ABUNDANCE OF CAUTION AS RELEASING STEAM IN FRONT OF THE OPERATOR MIGHT RESULT IN A SERIOUS INJURY. MANUFACTURER REFERENCE NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572112 91-SERIES DISINFECTOR, MEDICAL DEVICES MEC GETINGE DISINFECTION AB 9128

    Patients

    Seq Age Sex Outcome Treatment
    1