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

Model Number AF14120CA00

Device Problems Unintended System Motion (1430); Unstable (1667)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/24/2020

Event Type  Injury  

Manufacturer Narrative

Please note that previous medwatch reports for this product may have been submitted under the registration number: (b)(4).Currently, these products are to be handled by arjohuntleigh abs complaint handling establishment and any medwatch reports will be submitted under registration #: (b)(4).The involved device was taken out of usage and evaluated by the arjo technician.The bath was partially off both rails, which made it wobbly when force was exerted on the side not supported by the rail.The investigation is on-going and further information will be provided in the next report.

Event Description

Arjo was informed about the event with involvement of freedom bath.It was reported that during bathing, a resident started moving and shaking the tub, and the device came off the sliding rails.The bathtub was partially off the rail causing it to tip a bit forward.No injury occurrence was reported.

Manufacturer Narrative

Arjo was informed about an event with involvement of freedom bath.It was reported that during bathing, a resident (unknown height and weight) started moving and shaking the tub and the device came off the sliding rails.The bathtub was partially off the rail causing it to tip a bit forward, but did not tip over.No injury occurrence was reported.The involved device was taken out of usage and evaluated by the arjo technician.The bath was partially off both rails, which made it wobbly when force was exerted on the side not supported by the rail.No malfunction related to floor attachments was found.The bath was reseated in rails and put back to usage.Freedom bath should be equipped with mounting rails (floor attachments), which need to be securely assembled to the floor.The bath should be placed on these rails to prevent its instability.These attachments should be checked every year during preventive maintenance.Detailed description of the installation process can be found in the assembly and installation instructions.According to the received information, a bath¿s loosening on the floor rails was not caused by any malfunction or deficiency of the device itself, but was a consequence of the device being moved and shaken during use.In summary, the bath was not up to manufacturer¿s specification as it was not fully engaged in the floor rails and was tilted forward, but no malfunction of the bath¿s components was detected.The device was used with the patient when the issue occurred, so it was directly involved in the event.This complaint was decided to be reported to the competent authorities in abundance of caution due to indication that the bath came off the rails during use and slightly tipped forward.

• 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: 11036511
• MDR Text Key: 223764411
• Report Number: 3007420694-2020-00192
• 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: 01/14/2021

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: AF14120CA00
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/24/2020
• Initial Date FDA Received: 12/18/2020
• Supplement Dates Manufacturer Received: 11/24/2020
• Supplement Dates FDA Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other