MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB PARKER BATH; ILM

Model Number AL11012-EU

Device Problem Temperature Problem (3022)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 08/03/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information will be provided upon conclusion of the manufacturer's investigation.

Event Description

On (b)(4) 2016 arjohuntleigh received a customer complaint where it was indicated that the resident was scalded in bath.The thermometer of the water showed 63,4 °c.On 24th august 2016, during interview with the user facility representative, additional information was provided.The bath was filled with water, the resident sat on the knees of the caregiver.When the resident's feet were put into the water, she cried out and was lifted out of the water.As a consequence of the event, the resident sustained scalding of second degree on the soles of both feet.Treatment was described as cleaning of wounds and skin transplantation.The resident spent about 2 weeks in hospital.

Manufacturer Narrative

(b)(4).An investigation was carried out into this complaint.When reviewing similar reportable events for parker bath we have found a low number of other similar cases where there was a risk to the patient because of too hot water.We have been able to establish that there is no complaint trend concerning this kind of event.Please note that arjohuntleigh manufactured about (b)(4) parker baths to date.Parker bath is a height adjustable bath system intended for assisted bathing.It is equipped with a thermostatic mixer that contains 3 temperature and pressure controlled cartridges.These cartridges are responsible for water temperature adjustment, and if these cartridges are damaged, inter alia by poor water quality, it is possible to get different water temperature than set.Instruction for use, which is provided with each device, contains information about safe and correct use of the product."always check the water temperature prior to placing bather in the bath or using shower." "check the temperature of the water by hand." the product in this complaint is subject to wear and tear.To preserve its performance and safety, preventive maintenance is to be carried out - a list of recommended steps can be found in instruction for use.In accordance to ifu, apart from the fact that the thermostatic mixer should be checked every year by qualified personnel, the caregiver is obliged to perform checks every month.There is also the following warning: "warning: the points on this checklist are the minimum the manufacturer recommends.In some cases due to heavy use of the product and exposure to aggressive environment, more frequent inspections should be carried out.Continuing to use this product without conducting regular inspections or continuing to use this product when a fault is found will seriously compromise the user and residents safety." from above, the root cause of this event appears to be a user error - not following warnings included in instruction for use concerning checking water temperature by hand and incorrect tub preparation for use by insufficient maintenance.This bath was out of the manufacturer's specification at the time of event.The device was being used for patient handling and in that way contributed to the event.The received information and our evaluation as described above shows that if all the warnings and recommendations were followed in accordance to instruction for use, there would be no patient or caregiver at risk.

• Brand Name: PARKER BATH
• Type of Device: ILM
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov, 24121 ; SW 24121
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 5924301
• MDR Text Key: 53798210
• Report Number: 3007420694-2016-00193
• Device Sequence Number: 1
• Product Code: ILM
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 09/29/2016,08/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Model Number: AL11012-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: 09/29/2016
• Distributor Facility Aware Date: 08/04/2016
• Device Age: 7 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 09/29/2016
• Date Manufacturer Received: 08/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2009
• 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: 39 YR
• Patient Weight: 40