BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    91-SERIES

    MDR report key: 10790440 · Received November 5, 2020

    Report

    Report Number
    9616031-2020-00037
    Event Type
    Malfunction
    Date Received
    November 5, 2020
    Report Date
    December 15, 2020
    Manufacturer
    GETINGE DISINFECTION AB
    Product Code
    MEC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    WHEN REVIEWING REPORTABLE EVENTS, WE WERE ABLE TO ESTABLISH THAT THERE WERE SEVERAL REPORTABLE COMPLAINTS REGISTERED IN GETINGE COMPLAINT HANDLING SYSTEMS DURING LAST 5 YEARS CONSIDERING THE ISSUE WHERE STEAM LEAK FROM PARTS AVAILABLE FOR THE CUSTOMER OCCURRED ON WASHER DISINFECTORS FROM 91 SERIES. ALL OF THEM WERE DECIDED TO BE REPORTABLE TO COMPETENT AUTHORITIES BASED ON THE POTENTIAL FOR THE ADVERSE OUTCOME UPON THE REOCCURRENCE, IN NONE A SERIOUS INJURY OR WORSE OCCURRED. AS IT WAS PROVIDED IN THE COMPLAINT RECORD THE DEVICE THAT TOOK PART IN THE EVENT WAS A WASHER DISINFECTOR FROM 91-SERIES, WITH SERIAL NUMBER: (B)(6) AND CATALOG NUMBER: 9120-001-CTOM. THE SERIAL NUMBER GIVES US INFORMATION THAT THE UNIT WAS MANUFACTURED ON 2016-04-05. ADDITIONALLY, INSTALLATION DATE IN THE FACILITY WAS PROVIDED AS 2016-07-28. THE INFORMATION COLLECTED TO DATE AND AS A RESULT OF THE PERFORMED INVESTIGATION ALLOWED US TO ESTABLISH THAT A ¿A40 DRAIN TEMP HIGH¿ ALARM WAS DISPLAYED ON THE DEVICE , WHICH IS TO WARN THE USER ABOUT THE ABNORMALITIES DURING THE CYCLE AND INTERRUPTION OF THE CYCLE. THE ABNORMAL CONDITIONS IN SUCH CASE ARE THE TEMPERATURE DRAINING WATER >60°C FOR MORE THAN 15 SEC. IN SUCH SITUATION THE HOT MOISTURE COULD BE CUMULATED IN THE CHAMBER. THE DEVICE¿S USER MANUAL IS INSTRUCTING THE OPERATOR WHAT ACTIONS SHOULD BE TAKEN TO CORRECT THE ERROR AND THOSE DO NOT REQUIRE AN OPENING OF THE DOOR. THIS IS MAINLY DUE TO THE FACT THAT IT MAY CONTRIBUTE TO THE UNEXPECTED STEAM ESCAPE THROUGH THE DOOR AREA, THEREFORE EXACTLY TO THE SITUATION AS ALLEGED BY THE CUSTOMER. AFTER THE EVENT OCCURRENCE, THE DEVICE AT HAND WAS INSPECTED BY THE GETINGE TECHNICIAN WHO ADJUSTED THE PARAMETERS FOR THE DRYING PHASE FOR ALL CYCLES BY EXTENDING THE TIME AND LOWERING THE TEMPERATURE. NO APPARENT TECHNICAL MALFUNCTION HAS BEEN FOUND TO BE A REASON OF THE SITUATION OCCURRENCE. PERFORMED INVESTIGATION IS POINTING TO THE MOST LIKELY ROOT CAUSE OF SITUATION OCCURRENCE RELATED TO ACTIVITIES PERFORMED BY CUSTOMER, WHICH WERE NOT IN LINE WITH INSTRUCTIONS GIVEN AS PART OF THE USER MANUAL. WHEN THE EVENT OCCURRED, THE DEVICE WAS DIRECTLY INVOLVED AND LIKELY DID NOT MEET ITS SPECIFICATION SINCE THE STEAM LEAKED OUT AND IT CONTRIBUTED TO EVENT. UPON THE EVENT OCCURRENCE THE DEVICE WAS NOT BEING USED FOR PATIENT TREATMENT. 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.

    Description of Event or Problem · 0

    MANUFACTURER'S REFERENCE NUMBER: (B)(6).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    ON (B)(6) 2020 GETINGE BECAME AWARE ABOUT ISSUE WITH ONE OF THE DEVICES ¿ 9120 WASHER DISINFECTOR. AT IT WAS STATED, AT THE END OF CYCLE EXCESS MOISTURE HAS BEEN LEFT IN THE CHAMBER. WHEN THE DOOR WAS OPENED BY THE OPERATOR, THE MOISTURE HAS BEEN RELEASED AND SETTING OFF THE SMOKE ALARM. THERE WAS NO INJURY OR DAMAGE REPORTED, HOWEVER WE DECIDED TO REPORT THE COMPLAINT TO THE COMPETENT AUTHORITIES IN ABUNDANCE OF CAUTION AS ANY UNEXPECTED MOISTURE LEAK FROM PARTS AVAILABLE FOR THE CUSTOMER MIGHT CAUSE BURNS. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1261301 91-SERIES DISINFECTOR, MEDICAL DEVICES MEC GETINGE DISINFECTION AB 9120

    Patients

    Seq Age Sex Outcome Treatment
    1