BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    91-SERIES

    MDR report key: 8226362 · Received January 8, 2019

    Report

    Report Number
    9616031-2019-00001
    Event Type
    Malfunction
    Date Received
    January 8, 2019
    Report Date
    February 4, 2019
    Manufacturer
    GETINGE DISINFECTION AB
    Product Code
    MEC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2017050 BY THE MANUFACTURER GETINGE DISINFECTION AB, (REGISTRATION NO. 9616031) ON BEHALF OF THE IMPORTER GETINGE GROUP LOGISTICS AMERICA, LLC (REGISTRATION NO. 3012092534). WE ARE AWARE THAT THIS IS PAST THE 30 DAY DEADLINE FOR REPORTING. WE HAVE REMINDED THE COMPLAINT HANDLER TO REVIEW FDA REPORTING GUIDELINES IN ORDER TO PREVENT THIS FROM HAPPENING AGAIN. THE ISSUE IS BEING INVESTIGATED BY MANUFACTURING SITE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2017050 BY THE MANUFACTURER GETINGE DISINFECTION AB, (REGISTRATION NO. 9616031) ON BEHALF OF THE IMPORTER GETINGE GROUP LOGISTICS AMERICA, LLC (REGISTRATION NO. 3012092534). WHEN REVIEWING REPORTABLE EVENTS FOR THE DEVICES BELONGING TO 91 SERIES, WE WERE ABLE TO ESTABLISH THAT THIS ISSUE IS A FIRST ONE WHERE A STEAM LEAK FROM THE DOOR AREA WAS REPORTED TO US. THE DEVICE INVOLVED IN THE INCIDENT IS A WASHER- DISINFECTOR, MODEL NUMBER 9120, WITH THE SERIAL NUMBER (B)(4). . THE UNIT WAS MANUFACTURED ON (B)(6) 2007 AND INSTALLED ON (B)(6) 2007. AS SUCH IT HAS BEEN IN USE FOR OVER 11 YEARS. BASED ON THE INFORMATION COLLECTED TO DATE WE CONFIRMED THAT AN ALARM OCCURRED DUE TO CLOGGED STEAM LINE. ACCORDING TO SERVICE MANUAL (B)(4). REV. B (DOC. REF. NO.), IN SUCH AN ALARM SITUATION, THE TECHNICIAN OR TRAINED OPERATOR OF THE DEVICE IS TO PRESS THE "CLEAR ALARM" BUTTON ON THE OPERATING PANEL THAT INDICATES ABORTING THE CURRENT PROCESS. OPERATOR IS TO ACKNOWLEDGE AN ERROR BY ENTERING PASSWORD TO THE CONTROL PANEL DISPLAY. AFTERWARDS, THE DEVICE IS TO BE DRAINED MANUALLY WITH CAUTION AND THE DOOR IS NOT TO BE OPENED IF AN INTERNAL TEMPERATURE IS HIGHER THAN 60 DEGREES. IF AN EMERGENCY OCCURS, THE MACHINE IS TO BE STOPPED WITH ONE OF THE EMERGENCY STOPS. IN THE INVESTIGATED SITUATION, IT APPEARS MOST LIKELY THAT AFTER THE ERROR WAS CLEARED FROM THE MACHINE IN ACCORDANCE TO GIVEN INSTRUCTION, THE USER OPENED THE DOOR OF THE DEVICE WITHOUT CHECKING THE TEMPERATURE INDICATION FIRST. THIS IMMEDIATE ACTION OF OPENING THE DOOR WITHOUT FOLLOWING THE INSTRUCTIONS TO NOT TO DO SO AFTER CHECKING THE TEMPERATURE AND WAITING FOR THE INTERNAL TEMPERATURE TO COOL DOWN RESULTED IN AN EXTERNAL LEAKAGE OF THE STEAM AND, CONSEQUENTLY, AN ACTIVATION OF THE FIRE ALARM. THERE WAS NO PERSONAL INJURY AS A RESULT OF THE STEAM ESCAPING FROM THE DEVICE, NOR FROM ANY REACTION TO THE FIRE ALARM. THIS ACTIVITY WAS POSSIBLE DUE TO THE WAY DEVICES OF THIS AGE AND BUILD YEAR WERE DESIGNED TO WORK. IT IS CLEAR FROM THESE FINDINGS THAT THE ISSUE WAS CAUSED BY THE USER NOT FOLLOWING USE INSTRUCTIONS. IN SUMMARY, WHEN THE EVENT OCCURRED, THE DEVICE DID NOT MEET ITS SPECIFICATION AS A CLOGGED STEAM LINE CAUSED AN ALARM OCCURRENCE. THIS TYPE OF ISSUE IS CONSIDERED TO BE EXPECTED AND RELATED WITH A NORMAL USAGE OF THE DEVICE AND CAN BE AVOIDED BY FOLLOWING THE PREVENTIVE MAINTENANCE GIVEN IN THE MANUAL. THE REPORTED INCIDENT HOWEVER RESULTED FROM USER NOT FOLLOWING USE INSTRUCTIONS AND THIS, IN COMBINATION, CONTRIBUTED TO THE EVENT. IN THE TIME WHEN THE EVENT OCCURRED, THE DEVICE WAS NOT BEING USED FOR PATIENT TREATMENT. GIVEN THE FINDINGS OF THIS INVESTIGATION 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 WASHER DISINFECTOR 9120. AS IT WAS STATED, THE STEAM LINE WAS CLOGGED AND STEAM LEAK OCCURRED. THE STEAM FILLED IN THE WHOLE ROOM AND THE OPERATOR OF THE DEVICE WAS STANDING NEXT TO THE WASHER DISINFECTOR. THERE WAS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL AS ANY UNEXPECTED STEAM LEAK FROM PARTS AVAILABLE FOR CUSTOMER MAY LEAD TO ADVERSE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18353 91-SERIES 9120 MEC GETINGE DISINFECTION AB 9120

    Patients

    Seq Age Sex Outcome Treatment
    1 Other