MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. FREEDOM BATH; BATH, HYDRO-MASSAGE

Model Number AF24104US00

Device Problem Installation-Related Problem (2965)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Type  Injury  

Manufacturer Narrative

According to the freedom bath instructions for use (ifu, document number 04.Af.02_14gb dated on december 2017 - delivered with this device), the equipment must be installed by appropriately trained personnel according to the assembly and installation instructions.Please note that in the ifu there are a few requirements that should be met prior to installation of the freedom bath, including these 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.¿ ¿floor attachments: the floor construction must be suitable for anchoring the bolts.¿ detailed description of the installation process can be found in the assembly and installation instructions (06.Af.02_9gb issued in february 2017 ¿ binding at the time of device manufacturing).There are mounting rails, which need to be securely assembled to the floor.When this step is completed, the bath should be placed on these rails, which prevent instability.These attachments should be checked every year during preventive maintenance.The device was not installed on customer site by the qualified arjo personnel.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.¿ from above we can conclude that this problem was most likely caused by user error ¿ the customer facility did not performed installation of the bath as per device labeling.Please note that if instructions for use and assembly and installation instructions are followed, there would be no patient or caregiver at risk.The bath was not up to manufacturer¿s specification as it was not correctly installed.It was unknown if the device was used with the patients.There was no indication of any adverse event occurrence.This complaint was decided to be reported to the regulatory authority in abundance of caution as it was indicated that the mandatory floor attachments were not installed, which could lead to risk of the device tipping.

Event Description

Arjo was informed by the customer that their freedom bath is able to tip over when someone leans too far.No adverse event was reported.The arjo representative visited the customer facility to evaluate the bath in question and found that it is unstable due to lack of floor attachments, which caused the potential risk reported by the facility.The floor attachments were installed by the arjo technician and bath was returned to use.

Manufacturer Narrative

The 'unique identifier (udi)' in section d was added and the 'manufacturing date' field in section g of this report has been corrected.

• Brand Name: FREEDOM BATH
• Type of Device: BATH, HYDRO-MASSAGE
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• MDR Report Key: 9928062
• MDR Text Key: 198776853
• Report Number: 3007420694-2020-00070
• Device Sequence Number: 1
• Product Code: ILJ
• 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: 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AF24104US00
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/10/2020
• Initial Date FDA Received: 04/06/2020
• Supplement Dates Manufacturer Received: 03/10/2020
• Supplement Dates FDA Received: 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other