BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CM320

    MDR report key: 6743450 · Received July 26, 2017

    Report

    Report Number
    9616031-2017-00026
    Event Type
    Malfunction
    Date Received
    July 26, 2017
    Date of Event
    June 29, 2017
    Report Date
    June 25, 2018
    Manufacturer
    GETINGE DISINFECTION AB
    Product Code
    MEC
    UDI-DI
    07340153700215
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2016015 BY THE MANUFACTURER GETINGE DISINFECTION AB, (REGISTRATION NO. 9616031) ON BEHALF OF THE IMPORTER GETINGE USA, INC., (REGISTRATION NO. 3004147784). ADDITIONAL INFORMATION WILL BE PROVIDED UPON RESULTS OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2016015 BY THE MANUFACTURER GETINGE DISINFECTION AB, (REGISTRATION NO. 9616031) ON BEHALF OF THE IMPORTER GETINGE USA, INC., (REGISTRATION NO. 3004147784). GETINGE RECEIVED A CUSTOMER COMPLAINT WHERE, AS STATED, A CART FELL OF FROM THE SMART TROLLEY. PLEASE NOTE THAT SMART TROLLEY ITSELF IS NOT A REGISTERED MEDICAL DEVICE, HOWEVER THE CM320 DEVICE IS REGISTERED AS A MEDICAL DEVICE SYSTEM. THE SMART TROLLEY IS AN ACCESSORY MANUFACTURED BY AN EXTERNAL SUPPLIER AND LABELED BY GETINGE STERILIZATON AB AND IT CAN BE USED WITH A WILD RANGE OF DEVICES. THIS ISSUE HAS BEEN ESCALATED TO THE TROLLEY'S SUPPLIER. ACCORDING TO THE INFORMATION PROVIDED BY THE SUPPLIER ALL TROLLEYS ARE CHECKED AFTER ASSEMBLY WITH ACCORDANCE TO THE PROPER PROTOCOL. MENTIONED PROTOCOL INCLUDED MANY STEPS OF FINAL INSPECTION WHICH ARE TO BE TAKEN BEFORE THE TROLLEY IS RELEASED FURTHER. IT HAS BEEN ESTABLISHED THAT DURING FINAL TESTING GENERAL FUNCTIONALITY TEST OF THE TROLLEY IS PERFORMED HOWEVER THE RETAINER RING (CIRCLIP) IS NOT CHECKED SPECIFICALLY. IT HAS BEEN ALSO ESTABLISHED THAT THERE IS A POSSIBILITY THAT DURING LOADING/UNLOADING PROCEDURE THE CIRCLIP COULD LOOSEN AND THIS MAY NOT BE NOTICED BY THE CUSTOMER AS IT IS LOCATED UNDER THE TROLLEY. THE CIRCLIP IS AN OFF-THE SHELF COMPONENT. IT NOT TAKING UP ANY FORCE IN THIS APPLICATION. ITS ONLY PURPOSE IS TO KEEP THE BOLT IN PLACE. IF THE GROVE IS CORRECT AND THE CIRCLIP IS CORRECTLY INSTALLED IT SIMPLY CANNOT DETACH BY ITSELF. IT IS POSSIBLE THAT THE RING WAS NOT PROPERLY INSTALLED HOWEVER COMPLAINT REVIEW DID NOT SHOW A TREND OF SIMILAR COMPLAINTS. AS A RESULT, WE CANNOT EXCLUDE ILL-JUDGED MAINTENANCE ACTIONS DURING THE DEVICE LIFETIME. IT HAS BEEN ESTABLISHED THAT WHEN THE EVENT TOOK PLACE THE DEVICE WAS LIKELY NOT UP TO THE MANUFACTURER SPECIFICATION AND IT DIRECTLY CONTRIBUTED TO THE OUTCOMES OF THE EVENT. IT HAS BEEN ALSO ESTABLISHED THAT WHEN THE EVENT TOOK PLACE THE DEVICE WAS NOT USED FOR TREATMENT OR DIAGNOSIS. GIVEN THE CIRCUMSTANCES AND THE FACT THAT THERE IS NO TREND OBSERVED FOR CUSTOMER COMPLAINTS WITH THIS FAILURE MODE, WE SHALL CONTINUE TO MONITOR FURTHER EVENTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    THE FOLLOW UP REPORT (MFR REPORT # 9616031-2017-00026) IS SUBMITTED DUE TO THE MISSING F/U 3 AND IT IS SUBMITTED TO CORRECT THE ERROR IN NUMBERING. THERE IS NO NEW INFORMATION REGARDING THIS CASE. THE FINAL REPORT (3004147784-2017-000266) WAS SENT ON 25/06/2018. THE DATE RECEIVED BY MFG IS THE DATE WHEN THE FDA REQUEST WAS RECEIVED (03.04.2025).

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2016015 BY THE MANUFACTURER GETINGE DISINFECTION AB, (REGISTRATION NO. 9616031) ON BEHALF OF THE IMPORTER GETINGE USA, INC., (REGISTRATION NO. 3004147784). ROOT CAUSE ANALYSIS OF THE ISSUE IS STILL UNDER INVESTIGATION. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2016015 BY THE MANUFACTURER GETINGE DISINFECTION AB, (REGISTRATION NO. 9616031) ON BEHALF OF THE IMPORTER GETINGE USA, INC., (REGISTRATION NO. 3004147784). THE EVENT IS BEING INVESTIGATED. ADDITIONAL INFORMATION WILL BE PROVIDED UPON RESULTS OF THE INVESTIGATION.

    Description of Event or Problem · 0

    ON (B)(4) GETINGE BECAME AWARE OF AN INCIDENT CAUSED BY ONE OF THE MEDICAL DEVICES MANUFACTURED BY GETINGE. FROM INFORMATION PROVIDED BY THE CUSTOMER AFTER THE WASHING PROCESS THE WASH CART FROM CM320 WASHER DISINFECTOR HAD BEEN TRANSFERRED ON THE UNLOADING CONVEYOR AND MOVED TO THE CLEAN SIDE. THE WASH CART DURING THE PROPER OPERATION SHOULD STOPPED WHEN REACHED END OF THE UNLOADER. HOWEVER IN THE CASE REPORTED BY THE CUSTOMER THE WASH CART OVERTURNED AND FELL DOWN TO THE GROUND. SERVICE TECHNICIAN WHO ARRIVED ON SITE REPORTED THAT STOP PIN WAS BROKEN. AS A RESULT OF THE EVENT NO INJURY HAS BEEN REPORTED. HOWEVER WE DECIDED TO REPORT THIS CASE IN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2016015 BY THE MANUFACTURER (B)(4).THE EVENT IS STILL BEING INVESTIGATED BY MANUFACTURING SITE AND CURRENTLY THE ISSUE IS CONSULTED WITH THE SUPPLIER. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525924 CM320 DISINFECTOR, MEDICAL DEVICES MEC GETINGE DISINFECTION AB CM320 07340153700215

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other