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

Model Number AR32111-US

Device Problem Unintended System Motion (1430)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The involved device was removed from use and evaluated by the arjo representative.According to the results of inspection, the relay on power board welded shut and caused damage of the hydraulic pump.The faulty power board and pump were replaced.The investigation is on-going and further information will be provided in the next report.

Event Description

Arjo was notified about an event with involvement of system 2000 bath.It was stated that during use of the device, while the patient was being transferred on bathing chair, the bathtub started to raise uncommanded.The caregiver was able to raise the chair up to avoid contact with raising bathtub.No injury was reported.

Manufacturer Narrative

Arjo was notified about an event with the involvement of a system 2000 bath.It was stated that during use of the device, while the patient was being transferred on bathing chair, the bathtub started to rise uncommanded and went to the top position.The caregiver was able to raise up the hygienic chair to avoid contact with bathtub.No injury was reported.The affected device was removed from use and evaluated by the arjo representative.According to the results of inspection, the relay on power board welded shut and caused damage of the hydraulic pump.The faulty power board (installed inside the power box) and hydraulic pump were replaced and disposed.It was not possible to determine what was the cause of the relay welding shut.This equipment is intended for bathing and showering hospital or care facility residents under the supervision of trained skilled nursing staff in accordance with the instructions outlined in arjo's operating and daily maintenance instructions.According to the collected information the bathtub started to raise up on its own, during transfer of the patient on the bathing lift, but the caregiver was able to avoid the collision of the devices (bath and the bathing chair).Please note that it was not possible to determine the cause of power board malfunction upon evaluation of the bath and the component was disposed after repair performed following inspection.Based on the available information we are able to determine two possible causes of the occurred issue.Firstly, the short circuit due to water ingress as it appears to be possible that water has leaked into the power box and come in contact with the electronics inside the assembly.The contact between the water and electronics could have led to short circuit and to the unintended movement.The second probable cause of the reported event is wear.Based on the performed review of a service history the faulty power board has not been replaced within last 6 years.Therefore, it is concerned likely that the part has not been replaced since manufacture, hence the malfunction could be related to wear.The system 2000 is subject to wear and tear and maintenance actions must be performed when specified to ensure that the product remains within its original manufacturing specification.The normal useful life of this equipment, unless otherwise stated, is ten (10) years, subject to required preventative maintenance as specified in the relevant product documentation.In conclusion, based on the all available information it was not possible to determine the cause of the reported event.The technical inspection revealed that the device was not up to manufacturer¿s specification after the event.According to the customer allegation, the bathtub was moving upward without pressing any button, so the device did not perform as intended.The bathtub was used for a patient hygiene and in that way it played a role in this event.The complaint was decided to be reported in abundance of caution, due to the possible scenario of event - uncommanded bath movement upwards while the patient was on the bathing lift, which could have caused a device destabilization and patient's fall.

• 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: 9488365
• MDR Text Key: 198516841
• Report Number: 3007420694-2019-00224
• 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: 01/13/2020

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: Other
• Device Model Number: AR32111-US
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/21/2019
• Initial Date FDA Received: 12/18/2019
• Supplement Dates Manufacturer Received: 11/21/2019
• Supplement Dates FDA Received: 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other