MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB PARKER BATH

Device Problems Calibration Problem (2890); Device Operational Issue (2914); Human Factors Issue (2948)

Patient Problem Superficial (First Degree) Burn (2685)

Event Type  Injury  

Event Description

Reference importer # (b)(4).

Manufacturer Narrative

(b)(4).An investigation was carried out into this complaint.When reviewing similar reportable events for parker bath we have found a very low number of other similar cases where there was risk to the patient because of too hot water.We have been able to establish that there is no complaint trend concerning these kind of events.Please note that arjohuntleigh manufactured about (b)(4) parker baths to date.The device was inspected by an arjohuntleigh representative at the customer site and found to be out of specification.The device was being used for patient handling and in that way contributed to the event.From the information received first degree burns (without blisters) - red skin, occurred as a result of this incident.Information regarding supplied water temperature during calibration - 55 degrees c additionally confirms that installation of complained parker was incorrectly performed.Water temperature was different than recommended in ifu and assembly and installation manual where site requirements section define recommended hot temperature among 60 degrees c and 80 degrees c.Instruction for use (04.Al.01_7gb from june 2012) provides information about safe and correct use of the product.It informs that the parker must be installed by appropriately trained personnel according to the assembly and installation instructions.Ifu warns also: "to avoid injury to both resident and caregiver, never modify the equipment or use incompatible parts." additional information provided by the originator of this complaint showed that there was an unauthorized modification of the product: "someone has taken a bath unattended and the thermostat was set to the highest position".From above we can conclude that this problem was caused by user error: user didn't followed warnings regarding calibration included in assembly and installation manual; water temperature was lower than 'hot water lower limit temperature'; settings has been modified by the customer - thermostat was set to the highest position.The received information and our evaluation as described above are showing that if parker's warnings and installation procedures were followed in accordance to instructions for use and assembly and installation manual, there would be no patient or caregiver at risk.We have not been able to find any contributing manufacturing anomalies.

• Brand Name: PARKER BATH
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov 2412 1; SW 24121
• Manufacturer (Section G): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov 2412 1; SW 24121
• Manufacturer Contact: pamela wright ; 12625 wetmore; ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 3764655
• MDR Text Key: 4470155
• Report Number: 9611530-2014-00024
• 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: User Facility,Company Representative
• Remedial Action: Repair
• Type of Report: Initial

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?: No
• Device Operator: Other
• Initial Date Manufacturer Received: 03/27/2014
• Initial Date FDA Received: 04/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1