MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. SYSTEM 2000; BATH, SITZ, POWERED

Model Number AR31300GB1010

Device Problem Temperature Problem (3022)

Patient Problems No Consequences Or Impact To Patient (2199); Superficial (First Degree) Burn (2685)

Event Date 07/04/2019

Event Type  malfunction  

Manufacturer Narrative

Aditional information will be provided upon investigation conclusion.

Event Description

The caregiver was showering the child hair in the bath.When the caregiver was checking the shower temperature (before rinsing the patient hair) the water stream from the shower handle become very hot.As a consequence the caregiver and patient sustained the redness and pain from hot water temperature.

Manufacturer Narrative

Arjo was notified about an event with involvement of system 2000 bath.The caregiver was showering the patient's hair in the bath.When the caregiver was checking the shower temperature (before rinsing the patient hair) the water stream from the shower handle become very hot.As a consequence the caregiver and patient sustained the redness and pain from hot water temperature.No information regarding treatment was provided.The claimed device was taken out of use and was evaluated by the qualified arjo representative.According to the results of inspection, very short-lasting peaks of water temperature were detected upon measurements without changes in read outs on bath thermometer (constantly showing 37 degrees).The arjo representative replaced components suspected to be faulty and performed routine adjustments, but these actions did not resolve the issue and did not allow to clearly determine the cause of fault.In order to satisfy customer's needs, the claimed bathtub was replaced with a new device.The system 2000 instructions for use (ifu; 04.Ar.12_13 issued in january 2017 - delivered with the claimed device) provides warnings and other supporting information regarding usage of the bathtub: "to prevent scalding, always check water temperature with your naked hand before directing the water on the patient.Do not use the gloves as it may insulate to the extent the water temperature can be misjudged.Point the flow of the water away from the patient." looking at the reported event's scenario the temperature increased after pressing the shower handle trigger.According to the ifu including information for showering the patient these guidelines should be followed by the caregiver: "[.] 6.Press shower button on the control panel (the led lights up green when active).7.Direct the shower handle away from patient 8.Press the trigger on the shower handle and direct the water stream away from the patient.Place your naked hand in the water stream and make sure the water temperature is not too hot or too cold.9.The display shows the temperature value.Allow a few seconds for the water to reach the preset temperature.[.]" system 2000 bathtub is equipped with the scalding protection feature which if a dangerous temperature level of 45 degrees celsius is reached shuts off the water in less than 10 seconds.The ifu informs user about procedure in case of scalding protection activation: "to prevent scalding if the scalding protection is activated, remove the patient from the bath immediately in a safe manner." the manufacturer has performed an in-house simulation with other system 2000 rhapsody bathtub, in order to recreate the malfunction in question by following the same actions as reported, but it could not have been duplicated.Further tests will be performed upon availability of the involved bathtub removed from the customer facility.It should be underlined that this event is a first presenting this type of malfunction and no report of similar incident has been received within last years.Therefore, the complaints will be monitored and tracked further in order to determine any existing issue not limited to this single event.According to the performed analysis the clear conclusion cannot be drawn, hence based on the limited information available to date the root cause is considered impossible to define.The investigation will be updated and follow-up reports will be submitted to the regulatory authorities as soon as further information relevant for defining event cause would become available.In summary, the inspection of the device confirmed that is the bath was not according to the manufacturer's specification.According to the customer allegation, the water temperature increased suddenly and scalded the patient and caregiver.The shower trolley was used for patient hygiene at the time of event.This complaint was decided to be reported to the regulatory authorities due to potential of serious injury if the event were to reoccur.

Manufacturer Narrative

Investigation in order to identify the cause of the occurred malfunction is still on-going.Additional information will be provided in the next report.

Manufacturer Narrative

Additional inspection of the involved bathtub was requested and information about its availability for such purpose is awaited.Investigation in order to identify the cause of the occurred malfunction is still on-going.Update will be provided in the next report.

Manufacturer Narrative

The claimed device was taken out of use and was evaluated by the qualified arjo representative.According to the results of inspection, very short-lasting peaks of water temperature were detected upon measurements.The arjo representative replaced components suspected to be faulty and performed routine adjustments, but these actions did not resolve the issue.The investigation is still on-going and final conclusion is not yet available.Further information will be provided within the next report.

Manufacturer Narrative

The investigation is still on-going and final conclusion is not yet available.Further information will be provided within the next report.

• Brand Name: SYSTEM 2000
• Type of Device: BATH, SITZ, POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• MDR Report Key: 8850115
• MDR Text Key: 152955465
• Report Number: 3007420694-2019-00122
• 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,Followup,Followup,Followup
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AR31300GB1010
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 24 YR