MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB MALIBU; BATH, SITZ, POWERED

Model Number AZR23110-GB

Device Problem Unintended System Motion (1430)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The involved bathtub was taken out of use after the event and it was evaluated by the arjo qualified representative.According to the inspection summary the device was in good condition and fully functional.No malfunction that could lead to the alleged sudden descent of the chair or its stuck during transfer was detected.It was decided to replace the chairlift actuator as a precaution.After replacing the chair lift actuator the device was tested and was confirmed to meet the manufacturer's specification.The investigation is on-going and additional information will be provided within the next report.

Event Description

It was reported that when caregivers were trying to bath the resident, the chair arm stopped working during the chair swing moment.The seat position was roughly halfway between fully out and fully in when it stuck.The caregivers securely removed the patient from the chair with the overhead hoist in bathroom.According to the received information, when the resident was taken off, the chair suddenly dropped to its lowest point.No injury occurrence was indicated.

Manufacturer Narrative

Arjo was notified about an event with involvement of malibu bath.It was reported that when caregivers were trying to bath the resident, the chair arm stopped working during the chair arm rotation movement.The seat position was roughly halfway between fully out and fully in when it stuck.The caregivers securely removed the patient from the chair with the overhead hoist in bathroom.According to the received information, when the resident was taken off, the chair suddenly dropped to its lowest point.No injury occurrence was indicated.The involved bathtub was taken out of use after the event and it was evaluated by the arjo qualified representative.According to the inspection summary the device was in good condition and fully functional.No malfunction that could lead to the alleged sudden descent of the chair or its stuck during transfer was detected.It was decided to replace the chair lift actuator and pcb as a precautionary measure.After replacement of both parts the device was tested and was confirmed to meet the manufacturer's specification.According to the customer's allegation the bathtub's chair stuck during use and then dropped down.Based on the results of performed bathtub evaluation no malfunction of the device was confirmed.The arjo technician replaced actuator and pcb as a precaution as looking at the scenario of reported event these assemblies were most possible to be related to the described malfunction.Please note that according to the malibu instructions for use (04.Az.00_8gb dated on june 2012) the malibu bath has to be serviced according to the preventive maintenance schedule (qualified personnel action/check).The last annual maintenance of the bathtub in question (including function check) was performed in november 2018 by the arjo qualified personnel member and the device was left safe to operate.In summary, the device was not up to the manufacturer's specification as according to the customer report the chair dropped down after the patient was removed from it.The lift was used for patient hygiene and in that way it played a role in this event.This complaint was decided to be reported to the competent authorities out of an abundance of caution as the alleged sudden and uncontrolled descending of the bath's chair could have result in an injury occurrence.

• Brand Name: MALIBU
• Type of Device: BATH, SITZ, POWERED
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov, 24121 ; SW 24121
• MDR Report Key: 8481739
• MDR Text Key: 140870344
• Report Number: 3007420694-2019-00057
• 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: 04/29/2019

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: Other
• Device Model Number: AZR23110-GB
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/29/2019
• Distributor Facility Aware Date: 03/08/2019
• Device Age: 6 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 04/29/2019
• Initial Date Manufacturer Received: 03/08/2019
• Initial Date FDA Received: 04/04/2019
• Supplement Dates Manufacturer Received: 03/08/2019
• Supplement Dates FDA Received: 04/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other