MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB FREEDOM BATH; BATH, HYDRO-MASSAGE

Model Number AF24104US00

Device Problem Installation-Related Problem (2965)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Please note that previous medwatch reports for this product may have been submitted for the manufacturing site arjo hospital equipment ab (under registration #(b)(4)).As of 2014 that number was de-activated due to the site no longer being a manufacturer and shipping product to the usa.From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh ab's complaint handling establishment and any medwatch reports will be submitted under registration # (b)(4).Additional information will be provided upon conclusion of the investigation.

Event Description

Arjohuntleigh was notified that during service of the bathtub performed at the customer facility by arjohuntleigh representative it was identified that device is not secured with the floor attachments.

Manufacturer Narrative

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 there was also no record of confirmation that bathtub was installed by arjo.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 (b)(4) 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 ((b)(4) 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.

• Brand Name: FREEDOM BATH
• Type of Device: BATH, HYDRO-MASSAGE
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov, 24121 ; SW 24121
• MDR Report Key: 7442464
• MDR Text Key: 106621528
• Report Number: 3007420694-2018-00097
• 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: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AF24104US00
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/17/2018
• Distributor Facility Aware Date: 03/21/2018
• Device Age: 8 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 05/17/2018
• Date Manufacturer Received: 03/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other