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

Model Number AR52101-EU

Device Problem Temperature Problem (3022)

Patient Problems Burn(s) (1757); Partial thickness (Second Degree) Burn (2694)

Event Date 11/18/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Arjohuntleigh received a customer complaint for system 2000 bath.It was reported that when the bathing procedure started, the temperature was set and checked.The resident was transferred to the bath using a lift.The caregiver did not take a look at the display in the meanwhile.After touching the water, the resident said it was far too hot.The caregiver checked the display again and found out that the temperature was raising.The resident was lifted out the bath immediately and placed on the bed.

Manufacturer Narrative

(b)(4).An investigation was carried out into this complaint.When reviewing similar reportable events for system 2000 baths we have found one other similar case where the user was scalded due to too hot fill or shower water.There is no complaint trend for this kind of events.System 2000 is a height adjustable bath system intended for assisted bathing.It is equipped with thermostatic mixer that contains 3 temperature and pressure controlled cartridges.The temperature control system is manual in this model, operated with a control knob from the front panel through a gear.There is an adjustable stop ring behind the control knob to set the maximum allowed temperature of the hot water.Instruction for use (ifu) is provided with each device.Ifu (operating and daily maintenance instructions 04.Ar.10/2 ca from september 2001) provides information about safe and correct use of the product.It informs that user must always make sure that: "the water/shower temperature is checked by hand before the bath".Assisted bathing of the patient is described in resident handling instruction (04.Ar.11/1gb from september 1999 - excerpt attached) which also points out importance of checking water temperature before use: "check the bath water temperature before the resident enters the water".Please note that device examination showed that the stop ring of the control knob was damaged.The exact cause of this failure is unknown, however there are several possibilities for this failure: - excessive force applied to the control knob when adjusting the temperature to the highest value, - attempts to overturn the knob outside the maximum allowed temperature, - the knob could have been incorrectly maintained as the ifu informs that every month the caregiver must "check that all screws, bolts and other joints are perfectly tight", - weakening of the stop ring due to its age.Due to the age of this bath, it should be considered to have it replaced.Despite fact that there was no obvious sign of damage, the age of the device is significant when this kind of the malfunction is occurring and this factor could have contributed to stop ring breakage.Looking at the date of production of this device, it was manufactured in 2004 and has already passed its operational lifetime as identified in the device labelling two years ago."the normal useful life of this equipment, unless otherwise stated, is ten (10) years, subject to required preventative maintenance as specified in the operating and daily maintenance instruction, the assembly and installation instructions and the spare part catalogue." our evaluation as presented above showed that the most likely cause of the reported scalding incident was related to user error as in accordance to product's operating and daily maintenance instructions water temperature should be additionally checked by a naked hand, not only by a displayed value.If system 2000's bathing procedures were followed in accordance to instruction for use, there would be no patient or caregiver at risk.The device was inspected by an arjohuntleigh representative at the customer site and found to be out of its specification.The device was being used for patient handling and in that way contributed to the event.

• Brand Name: SYSTEM 2000
• Type of Device: HYDRO-MASSAGE GATH, INSTITUTIONAL
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov, 24121 ; SW 24121
• Manufacturer (Section G): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov, 24121 ; SW 24121
• Manufacturer Contact: kinga stolinska ; ks. wawrzyniaka 2; komorniki,, TX 62-05-2 ; PL 62-052 ; 2103170412
• MDR Report Key: 6169153
• MDR Text Key: 62249685
• Report Number: 3007420694-2016-00252
• Device Sequence Number: 1
• Product Code: ILM
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 01/11/2017,11/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Model Number: AR52101-EU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/11/2017
• Distributor Facility Aware Date: 11/21/2016
• Device Age: 132 MO
• Event Location: Nursing Home
• Date Report to Manufacturer: 01/11/2017
• Date Manufacturer Received: 12/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 44 YR
• Patient Weight: 85