MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB SYSTEM 2000; BATH, SITZ, POWERED

Model Number AR31811US1010

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Urinary Tract Infection (2120); No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The investigation is ongoing and further information will be provided in the next report.

Event Description

The customer facility has requested for verification of the system 2000 bath disinfectant system due to ongoing urinary tract infections (uti) issues with residents at this facility.Arjo representative visited the customer's site to verify the device functioning as per request.According to the results no malfunction was indicated and device was working according to specification.Arjo was not informed neither about any specific case of uti nor allegation that the arjo bath was source of the infection.Therefore, this report was submitted in abundance of caution.

Manufacturer Narrative

Please note that patient code and device code fields in section h.6 were corrected.The customer facility requested for verification of the system 2000 bath disinfection system 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 functioning as per request.No malfunction was found and the device was working according to the manufacturer¿s specification.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, it was functioning correctly and was performing according to the manufacturer specification.This complaint was decided to be reported to the regulatory authorities in abundance of caution due to indication of ongoing uti (urinary tract infections) with residents at the customer facility, that potentially may be related to arjo devices.

• Brand Name: SYSTEM 2000
• Type of Device: BATH, SITZ, POWERED
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov 24121 ; SW 24121
• MDR Report Key: 9749163
• MDR Text Key: 198756156
• Report Number: 3007420694-2020-00039
• Device Sequence Number: 1
• Product Code: ILM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AR31811US1010
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/29/2020
• Initial Date FDA Received: 02/25/2020
• Supplement Dates Manufacturer Received: 01/29/2020
• Supplement Dates FDA Received: 03/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other