Arjo was notified that during service of the freedom bathtub performed at the customer facility by arjo representative it was identified that device is not secured with the floor attachments (p/n: afa0110).The customer facility maintenance manager stated that they had never had an issue with this device tilting or any issues of this nature.The arjo representative suggested customer to install the lacking fixtures.No event occurrence was reported in this case.The claimed bathtub was not under arjo service contract and service was performed upon the customer request.There was also no record of confirmation that bathtub was installed by arjo.The initial customer repair request was to inspect the door seal, which's malfunction caused water leakage.The arjo representative replaced two door seals, but replecement of those components is not associated with the subject of this investigation - missing floor fixing assembly.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 operating and product care instructions (ifu, document number 04.Af.02_5gb dated on june 2007) 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 the assembly and installation instructions (06.Af.02_4gb issued in may 2007) includes requirements regarding floor attachments: "the sliding rails provided in the installation kit have to be used when installing freedom bath.The floor construction must be suitable for anchoring the bolts." (p.6) detailed description of the installation process is included in the assembly and installation instructions.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.The floor fixtures as a mechanical attachment should be checked every year during preventive maintenance.The bath was not up to manufacturer's specification, but there is no indication of any incident or adverse event occurrence.This issue was reported in abundance of caution as it was indicated that the mandatory floor attachment was not installed, what, under some circumstances, could lead to risk of 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.
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