MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z.O.O. FREEDOM BATH

Model Number AF24104US00

Device Problems Leak/Splash (1354); Device Operational Issue (2914); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/02/2015

Event Type  malfunction  

Event Description

Initially it was reported by arjohuntleigh representative that caregiver slipped outside of the bath.During bathing of resident, staff noticed water leaking from base of door.Towels were used to control water flow, floor drain was covered and caused water to flow into hallway.At this point staff member walked and slipped on the water.He did not sustain any body injuries.Was asked to go home and change clothing but refused and continued his regular work schedule.Device examination included in incident description form (idf) showed that tub door liner, door track and door seal had good amount of soap scum build up.All function test on tub and door tested to oem specs per maintenance and repair manual (mrm) documents per ah representative: "due to the amount of soap scum build up, this caused water to bypass the door seal causing water to leak on the floor.Door liner, door track and door seal had soap scum build up"."tub was once again used on the following day even though tech stated to not use.Customer stated that tub worked to oem specs the following day with no leaks".Additional comment made by arjohuntleigh's representative: "the amount of soap scum build is believed to have caused tub to leak.Since customer tried to control water by using towels, they accidentally covered up the floor drain which caused water to build up and flow out of tub room.This is the reason someone walked by the tub room and slipped on the water.As stated by the customer, staff member was not hurt and continued his regular work schedule".

Manufacturer Narrative

This report is being filed under exemption (b)(4) by arjohuntleigh (b)(4).On behalf of the importer arjohuntleigh, inc.(b)(4).Please note that previous medwatch reports for this product may have been submitted for the manufacturing site arjo hospital equipment (b)(4)due to the site no longer shipping product to the usa.From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh (b)(4) complaint handling establishment.An investigation was carried out into this complaint.When reviewing similar reportable events freedom bath we have found very low number of other similar cases.There is no complaint trend concerning these kinds of events.(b)(4).The device was inspected by an arjohuntleigh representative at the customer site and found to be out of its specification - tub door liner, door track and door seal had good amount of soap scum build up.No other device malfunction was found that could contribute to reported problem.The device was being used for patient handling and in that way contributed to the event.A "5 why" analysis has been performed in relation to reported incident.We came to a conclusion that the reported problem - caregiver slipped because of wet floor, due to a leaking door, in turn caused by a blocked seal.It is most likely related to soap residue build up in involved bath, as per arjohuntleigh representative : 'this caused water to bypass the door seal causing water to leak on the floor.Door liner, door track and door seal had soap scum build up".Provided information showed also that it was possible to recreate the reported event only with soap residues.Product for use (ifu) is equipped with each device.Ifu (b)(4) provides information about correct and safe use of the product.It informs about cleaning and disinfecting procedures are necessary after each use of the device.Frequency of this action is described in care and preventive maintenance section.In accordance to this labeling, the user is obliged to clean door strip/seal and under the tub every day.Received information showed that seal was dirty with soap residues.From above evaluation and comments made by arjohuntleigh representative we can state that this failure - leaking door was caused by user error - not following ifu's recommendation regarding cleaning of the device.Additionally, slippage is a sudden or involuntary movement where the person loses foothold, as on a smooth surface.The leakage of the water doesn't cause it by itself, but these kind of events are considered to be unfortunate accidents.There are also other factors that need to appear to cause this incident, e.G, lack of carefulness, smooth or soapy surface.Problem described in complaint (b)(4) concerns situation where the caregiver noticed water on the floor, however she didn't take precautions to prevent slippage.Therefore we consider this event to be isolated incident where the end user was not paying appropriate attention and take reasonable precautions to avoid this incident.(b)(4).

• Brand Name: FREEDOM BATH
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z.O.O.; ul. ks. wawrzyniaka 2; komorniki 0000 6205; PL 000062052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. wawrzyniaka 2; komorniki 0000 6205; PL 000062052
• Manufacturer Contact: pamela wright ; 1625 wetmore, ste. 308; komorniki; san antonio, TX 78247-0000 ; 2102787040
• MDR Report Key: 4449912
• MDR Text Key: 5382580
• Report Number: 3007420694-2015-00021
• Device Sequence Number: 1
• Product Code: ILM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 01/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AF24104US00
• 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: 01/21/2015
• Distributor Facility Aware Date: 01/02/2015
• Event Location: Nursing Home
• Date Report to Manufacturer: 01/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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): Other
• Patient Weight: 59