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

Model Number AP31801US0010

Device Problem Unintended System Motion (1430)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/20/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information will be provided upon the investigation conclusion.

Event Description

Arjo was informed about an event with involvement of system 2000 bathtub.It was reported that during a bath, the bath began to rise uncommanded to the maximum height with resident in it.It is unknown if the patient was sitting on the bathing lift.The resident was manually removed from the bathtub.No injury was reported as a result of this event.

Manufacturer Narrative

Arjo was informed about an event with the involvement of system 2000 bathtub.It was reported that during a bath, the device began to rise unintentionally to the maximum height with resident in it.The raising button was still in "on" position, when the bathtub was going up.It was not possible to lower the bathtub, when it reached maximum height.According to the further information collected the resident was sitting on the non-arjo bathing mesh chair.The resident was manually removed from the bathtub by several customer facility employees.No injury was reported as a result of this event.The review of reportable events with the involvement of the system 2000 bath in last years, revealed a low number of similar incidents.The bathtub was evaluated by the arjo representative.According to the inspection results the overlay panel was found defective.The faulty part was replaced and device was tested to confirm its compliance with the manufacturer's specification.No visible damage was noticed.The faulty overlay panel was not available for further evaluation as it was disposed after repair of the bathtub.Please note that the claimed device was not under the arjo service agreement and its service history was not made available.Despite our best efforts none of the potential causes presented above could have been confirmed as the defective assembly was replaced and disposed after the repair.On the basis of the available information, we were able to determine only the possible causes of the occurred event.It appears to be probable that water has leaked into the panel 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 uncommanded movement.The second probable cause of the reported event is wear of the button material.The control panel of the device is equipped with push buttons made of rubber which is subjected to normal wear.Based on the collected information the raising button was still at "on" position and could not go to the "off" mode.This caused the hydraulic pump to run still and the bathtub to raise.The faulty overlay panel was used for over 6 years, during which it could have been subjected to a wear and tear, depending on the way it was utilized e.G.Pressing buttons too hard/by too many times, which could result in losing its original properties.The system 2000 is subject to wear and tear, and the following actions must be performed when specified to ensure that the product remains within its original manufacturing specification.Each bath has to be serviced according to the preventive maintenance schedule by the qualified personnel.Please note that the instructions for use booklet delivered with the involved device (ifu 04.Ar.12_1gb issued in june 2010) informs the device user about the recommended preventive maintenance actions to be performed on a regular basis, such as: "every week: perform functionality test, visually check all exposed parts" (p.42).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.This complaint was decided to be reported in abundance of caution, due to the limited initial information about the effect the bath movement could have caused.In course of the investigation it was clarified that the malfunction observed did not affect the patient nor caregiver safety.This type of malfunction in unlikely to cause or contribute to any adverse event upon reoccurrence, as long as the safety instructions are followed.The probability of occurrence for the harm is remote.The patient can be safely removed from the bathtub with usage of the solution chosen by caregiver or other device operator - as it was reported in this particular complaint.

• 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: 7689630
• MDR Text Key: 114434132
• Report Number: 3007420694-2018-00143
• 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: 08/10/2018

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: AP31801US0010
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/10/2018
• Distributor Facility Aware Date: 06/20/2018
• Device Age: 6 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 08/10/2018
• Initial Date Manufacturer Received: 06/20/2018
• Initial Date FDA Received: 07/16/2018
• Supplement Dates Manufacturer Received: 06/20/2018
• Supplement Dates FDA Received: 08/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other