MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB SYSTEM 2000; BATH, HYDRO-MASSAGE

Model Number AR32201-EU

Device Problem Failure to Disinfect (1175)

Patient Problem Decreased Respiratory Rate (2485)

Event Date 09/19/2021

Event Type  Injury  

Manufacturer Narrative

Please note that previous medwatch reports for this product may have been submitted under the registration number (b)(4).Currently, these products are to be handled by arjohuntleigh abs complaint handling establishment and any medwatch reports will be submitted under registration # (b)(4).The involved device was removed from use and evaluated by the arjo representative.Device in good general condition.It was indicated that arjo clean set up was not correct so the product concentration was too high and the tub was not rinse correctly.The supplemental report will be sent upon availability of the conclusion of the investigation.

Event Description

Arjo was notified about an event with involvement of the system 2000 bath.It was reported that the patient (child) was taking a bath and a few minutes after had a respiratory distress.Emergency service was called to check the patient, they gave him a bronchodilator.It was indicated that arjo clean set up was not correct so the product concentration was too high and the tub was not rinse correctly.

Manufacturer Narrative

Arjo was notified about an event with involvement of the system 2000 bath.It was reported by the customer that the patient (a child) was taking a bath and a few minutes after had a respiratory distress.Emergency service was called to check the patient, they gave him a bronchodilator.The involved device was removed from use and evaluated by the arjo representative.Device was found to be in good general condition.During a device inspection, the arjo technician noticed that arjo clean product concentration was too high and the tub was not rinse.The disinfectant bottle is located under the control panel lid and under the shampoo and bath oil bottles.The disinfectant bottle cap is adjustable and regulates the disinfectant/water ratio.Under the control panel lid, there is a disinfection spray handle and a flowmeter.The flowmeter shows the liquid mix ratio between the disinfectant and water.By hand-adjustment of the bottle cap the user is able to get the right mix ratio (according to draw which is presented in ifu).The instructions for use for system 2000 baths includes the following information: - replacement of the disinfectant bottle and instruction how to check and adjust the liquid mix ratio on the flowmeter: ¿adjust the water temperature until it reaches approximately 25°c (77°f) to eliminate disinfectant fumes.¿ ¿spray disinfectant in the bath tub.Keeping an eye on the flowmeter.¿ ¿check the liquid mix ratio on the flowmeter so that it is in accordance with the setting range stated in this ifu¿ (according to draw which is presented in ifu) ¿if necessary, adjust the bottle cap by hand to get the right mix ratio.¿ additionally the ifu includes detailed description how to disinfect the equipment and clean the bath after disinfection to remove disinfectant, inter alia: "rinse all parts clean with plenty of water having a temperature of approximately 25°c (77°f) using the shower handle to remove disinfectant¿ ¿wet a new cloth with water and remove all traces of disinfectant on contact areas.The cloth should occasionally be rinsed in running water when removing disinfectant.¿ based on the information collected and our evaluation performed we consider that the high concentration and presence of arjo disinfectant during the patient bath procedure had an impact on the patient reaction ¿respiratory distress¿.The awareness training was provided to the involved caregiver staff after the event with the subject "how to set up the disinfection programmation".In conclusion, the device was used for patient handling at the time of incident occurrence and in that way contributed to the event.The device was found to be in good condition, however did not perform as intended due to presence of high concentration of arjo disinfectant and therefore failed to meet its specification.The complaint was decided to be reported to the competent authorities due to indication of the patient exposure to concentrated disinfectant which resulted in a serious injury.

• Brand Name: SYSTEM 2000
• Type of Device: BATH, HYDRO-MASSAGE
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov 24121 ; SW 24121
• MDR Report Key: 12545678
• MDR Text Key: 273745510
• Report Number: 3007420694-2021-00129
• Device Sequence Number: 1
• Product Code: ILJ
• 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: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: AR32201-EU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization