Please note that patient code and device code fields in section h.6 were corrected.The customer facility has requested verification of five arjo system 2000 baths and their disinfection systems due to ongoing urinary tract infections (uti) with residents at this facility.There was no allegation that arjo bath was a source of the infection, also there was no microbiological test result nor other evidence provided.Arjo representative visited the customer's site to verify the device functionality as per request.According to the results of technical evaluation performed for bath of serial number (b)(6), no malfunction of the disinfection system was found.However hydro massage button was broken off panel, this failure is not considered to be related with the issue alleged by the customer.Considering the above, no relation between any infection case and arjo device was established.Moreover, arjo was not aware of any further information regarding customer investigation of the infection contributory factors.The device in question was equipped with a disinfection system, which according to the results of technical evaluation was working as intended.Equipment fitted with a bath tub disinfection device must be disinfected according to the instructions established in the operating and product care instructions.Please note that system 2000 operating and product care instructions (opci; 04.Ar.09_9 ¿ binding at the time this device was manufactured) provides user with the guidelines regarding proper performance of a disinfection procedure: ¿always make sure that: (¿) equipment is properly disinfected after each bath.¿ ¿make sure that there is an appropriate mixture of disinfectant liquid to the water by means of checking the flow meter.¿ the care and maintenance section of opci also includes actions related to proper disinfection of device that shall be carried out in accordance with the preventive maintenance schedule on regular basis: ¿every day cleaning/disinfection.Rhapsody/primo has to be cleaned immediately after use.Arjo cleaning agents and liquid treatment should be used in recommended concentrations.(¿)¿ ¿every month: remove and clean the strainers in the shower heads (¿)¿ please note that this system 2000 unit was manufactured in 2010, so over 9 years before arjo received this complaint.Based on the performed analysis it was not possible to neither confirm the correlation between this bath and uti cases, nor to identify a potential root cause of their occurrence.According to our best knowledge, this type of infections can be caused by multiple factors and may origin from various sources.As per information collected to date, it appears likely that customer facility was not able to determine with absolute certainty the source of infections, hence took applicable actions - part of which was verification of the bath operation.In summary, according to the gathered information the involved system 2000 bath was most probably used for patients hygiene, but no specific event was reported.Based on the performed evaluation of the device, although the bath was not performing according to the manufacturer specification, the disinfection system was functioning correctly.There have been 5 complaints deemed reportable to competent authorities in abundance of caution due to indication of ongoing uti infections, which residents at one customer facility might develop in relation to arjo device.Five events have been reported under the following mdr's numbers: 3007420694-2020-00039, 3007420694-2020-00040, 3007420694-2020-00041, 3007420694-2020-00042, 3007420694-2020-00043.
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