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

Model Number AF14104US00

Device Problem Installation-Related Problem (2965)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 2018-jan-15 arjohuntleigh was notified, that freedom bath was being used by customer without mandatory floor attachments installed.No event in use occurred and no patient involved.The customer initially raised a service request due to worn door membrane and seal causing leaks.

Manufacturer Narrative

On 2018-jan-15 arjohuntleigh was notified by customer facility, that arjohuntleigh freedom bath requires service due to found water leaks.On 2018-jan-15 the arjohuntleigh representative visited the customer facility and during technical evaluation it was indicated that worn door membrane and seal were causing water leaks.During further inspection, technician found that bathtub was being used even though the mandatory requirement of mounting the bath base to the floor was not followed.No adverse consequences were reported.The technician conducted further evaluation and found the device is not mounted to the floor with the mandatory floor attachment kit (afa0110).According to the technician, bathtub was stable as it was sat on a flat and level floor.The floor kit was not used because the floor in this facility was heated with water lines (floor heating).It should be underlined that the customer was informed, if the bathtub is not installed properly and in compliance with the manufacturer recommendations, it poses a tipping over hazard.The review of similar reportable events with the involvement of the freedom bath in last 5 years, revealed a low number of cases where it was indicated that bathtub floor attachments were not installed.According to freedom bath instructions for use (ifu, document number 04.Af.02_11gb dated on june 2013) which was delivered with this device, the equipment must be installed by appropriately trained personnel according to the assembly and installation instructions (p.5).Please note that in the ifu there are a few requirements that should be met prior to installation of the freedom bath, including this related to securing the device: "actions before the first use: make sure that the bath has been installed according to the assembly and installation instructions." (ifu, p.7) "floor attachments: the floor construction must be suitable for anchoring the bolts." (p.7) based on the information provided by arjohuntleigh representative the facility floor of the room in which the bathtub was localized was not suitable for floor attachments installation due to floor heating.The detailed description of the installation process to be followed, can be found in the assembly and installation instructions (06.Af.02_5gb).The sliding rails (or floor attachment kit) need to be securely assembled to the floor.When this step is completed, the bath should be placed on these rails, which prevent instability.This attachment should be checked every year during preventive maintenance.The involved device was not installed on customer site by arjohuntleigh qualified personnel, but by the 3rd party contractor.Based on the available information it may be stated that customer omitted the manufacturer safety requirements regarding bathtub installation.Please note that ifu refers to this kind of issues within the following statement: "unauthorized modifications on any arjohuntleigh equipment may affect its safety.Arjohuntleigh will not be held responsible for any accidents, incidents or lack of performance that occur as a result of any unauthorized modification to its products." (p.4) installation kit, which was not mounted to the floor, can be ordered by the customer separately as a spare part under number afa0110.The customer facility needed to arrange an installation with 3rd party with which the customer facility had an installation contract.The bath was not up to manufacturer's specification, but there is no indication of any incident or adverse event.This issue was reported due to potential for adverse event resulting from increased risk of the device tipping.Please note that if every point from instructions for use and assembly and installation instructions was followed, there would be no patient or caregiver at risk.

• Brand Name: FREEDOM BATH
• Type of Device: BATH, SITZ, POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP Z O.O; ks. wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• MDR Report Key: 7211951
• MDR Text Key: 98297686
• Report Number: 3007420694-2018-00018
• 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
• Report Date: 02/06/2018

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?: Yes
• Device Operator: No Information
• Device Model Number: AF14104US00
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/06/2018
• Distributor Facility Aware Date: 01/15/2018
• Device Age: 3 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 02/06/2018
• Initial Date Manufacturer Received: 01/15/2018
• Initial Date FDA Received: 01/23/2018
• Supplement Dates Manufacturer Received: 01/15/2018
• Supplement Dates FDA Received: 02/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other