MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP Z O.O SYSTEM 2000; BATH, HYDRO-MASSAGE

Model Number AP31300GB1010

Device Problem Arcing (2583)

Patient Problem No Patient Involvement (2645)

Event Date 09/26/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that while doing a repair on the bathtub the arjo engineer was re-tightening a screw on the device's control box, when a large spark appeared and the main site circuit breaker tripped.No patient involved.No injury occurred.

Manufacturer Narrative

Device manufacture date was updated as the date provided in previous reports was not accurate.It was reported that while doing a repair on the bath the arjo qualified representative was re-tightening a screw, when the large spark appeared and the bath tripped the main circuit breaker in the facility.The engineer was holding the plastic handle of screw driver and was not touching the metal shaft, so did not get an electrical shock.The engineer was most probably re-tightening the control box torx screw and then the spark was observed.No patient or caregiver involved and no injury occurred.The bathtub was inspected after the event with the assistance of another arjo personnel member.On examining the wiring it was found that there was a live wire with bare connector cable tied onto the bath frame with a few other wires.This wire was connected up to the 230v side of the pcb inside the bath.It was concluded that this wire is not required to be plugged into the pcb if the optional module (sound & vision control box) is not fitted.The wire has been disconnected and removed from the bath and the bath put back into use.The investigation for the reported event was conducted.It was established that the cable with bare end was added to the product due to the design upgrade.According to the analysis of the technical documentation the additional cable supplies power from the mpa control box to sound & vision control box.Mpa (modular pumped airgap) system was implemented into the design of system 2000 in february 2017.It is a pumped water supply system with tank as air gap available in models p200+/p220/ p300 for the united kingdom market.The mpa has a pumped airgap to prevent backflow.First bathtub with this system was manufactured in april 2017.The mpa improvement was added to the design of system 2000 to assure that the bathtub is compliant with wras requirements for united kingdom.Arjo has received wras approval for system 2000 in march 2017.The product engineering change, which implemented the mpa system affected multiple areas, including design of the bath assemblies and manufacturing instructions.It also introduced into design the cable connecting mpa control box with the sound & vision control box.Based on the collected information the type of mpa control box assembly should be different depending on the configuration of the bathtub.If the bath is not equipped with the sound & vision control box, therefore the cable in question should not be present in the mpa control box.The issue was noticed shortly after release of upgraded design and the engineering change covering several areas was raised.It included a request to create different versions of mpa control boxes to match the given configuration of bath.Looking at the event itself and based on the collected information, the accidental connection to the power supply could have occurred during maintenance of the device as the wire most probably was not under voltage before.Please note that it is not possible to confirm with absolute certainty if in case of this bathtub the wire was accidentally connected by the arjo representative during service.Please note that currently depending on the model of the system 2000 bathtub and included functionalities the build of the control box is different.The control box and associated parts are inside the bathtub covers and user of the device does not have direct access to them.The system 2000 instructions for use (04.Ar.12_11 issued in january 2017) delivered with the claimed device provides safety warnings regarding the electrical protection, which should be followed by the device owner: "to avoid electric shock, make sure that the equipment is connected to: continuously powered supply mains with protective earth.Separate fuse and ground fault circuit interrupter (gfci).A mains disconnection device.Equipotential bonding point.All installations must be in accordance with local codes and regulations." moreover, system 2000 maintenance and repair manual (09.Ar.07_7) includes the following warnings: "make sure that the water and power is shut off before removing any covers.Be aware of remaining pressure and over temperature in closed vessels after shut off." "check all vital parts for corrosion and damage (including: all electrical cabling)." the system 2000 design was also tested and confirmed to be compliant with the (b)(4).In summary, according to the received information the large electrical spark appeared and the bath tripped while the service of bath was being done.The bath was not used for patient hygiene at the time of event.This complaint was decided to be reported to the competent authorities based on the risk of electric shock when this kind of malfunction recurs.

Manufacturer Narrative

The bathtub was inspected by the arjo qualified personnel after the incident.It was found that wire with a bare end was connected to the power supply in the control box.Based on the collected information, the accidental connection to the power supply could have occurred during maintenance of the device as the wire was not under voltage before.The wire was removed from the bathtub.The investigation on the reported incident in order to establish the cause of its occurrence is ongoing.The information collected to date is under review and analysis, but the final conclusion is not yet available.Additional information will be provided within the next report.

Manufacturer Narrative

The investigation is ongoing, but the results are not available yet.The final conclusion will be provided as soon as possible.

Manufacturer Narrative

The wire in question is a power connection for another optional assembly and functionality not available in this model of system 2000 bathtub.In course of the investigation, it has not been yet possible to determine the exact cause due to which this part was mounted and under voltage.The member of arjo qualified personnel, who was directly involved in the incident (performed service), is no more the company employee and could not contribute to the investigation.Please note that depending on the model of the system 2000 bathtub and included functionalities the build of the control box is different.The control box and associated parts are inside the bathtub covers and user of the device does not have direct access to them.Further collection of information and review to finalize the investigation aiming to provide the conclusion is ongoing.

• Brand Name: SYSTEM 2000
• Type of Device: BATH, HYDRO-MASSAGE
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP Z O.O; ks. wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• MDR Report Key: 7994522
• MDR Text Key: 125101334
• Report Number: 3007420694-2018-00205
• Device Sequence Number: 1
• Product Code: ILJ
• UDI-Device Identifier: 05055982713917
• UDI-Public: (01)05055982713917(11)170407
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/05/2019

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: AP31300GB1010
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/05/2019
• Distributor Facility Aware Date: 09/26/2018
• Device Age: 1 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 02/05/2019
• Initial Date Manufacturer Received: 09/26/2018
• Initial Date FDA Received: 10/23/2018
• Supplement Dates Manufacturer Received: 09/26/2018; 09/26/2018; 09/26/2018; 09/26/2018
• Supplement Dates FDA Received: 11/21/2018; 12/20/2018; 01/18/2019; 02/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other