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

Model Number AUL4335-GB

Device Problem Device Fell (4014)

Patient Problems Fall (1848); Pain (1994)

Event Date 12/04/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The involved device was taken out of use and evaluated by the arjo representative.The bathtub was found to be in good overall condition, in line with its age.It was fully function tested including attaching and detaching subchassis from seat frame.No malfunction was found.The investigation is on-going and further information will be provided in the next report.

Event Description

Arjo was notified about an event with involvement of malibu/sovereign bath.It was reported by the customer facility that the bath's integrated transfer chair tipped over with patient on it, detached from lifting arm and fell to the floor.The patient struck floor with head and shoulder.A&e was attended with possible ligament damage to neck, but the resident was discharged back to home with pain relief.The incident occurred on preparing to bath the patient.The resident was hoisted onto bath chair in the bedroom by one caregiver and transferred into bathroom.Then the patient was took over by the second caregiver and on attempting to remove the chair's sub chassis the bath seat fell to the floor.

Manufacturer Narrative

Arjo was notified about an event with involvement of malibu/sovereign bath.It was reported by the customer facility that the bath¿s integrated transfer chair tipped over with patient on it, detached from lifting arm and fell to the floor.The incident occurred on preparing to bath the patient.The resident was hoisted onto bath chair in the bedroom by one caregiver and transferred into bathroom.Then the patient was took over by the second caregiver and on attempting to remove the chair¿s sub chassis the bath seat fell to the floor.The patient struck floor with head and shoulder.Initially the patient did not complain of any pain, but on moving the chair she complained of pain to her neck.A&e was attended with possible ligament damage to neck, but the resident was discharged back to home with pain relief.The involved resident was totally dependent on staff for all transfers, which were performed with use of a passive hoist.The patient¿s sitting balance was insufficient.The involved device was taken out of use and evaluated by the arjo representative.The bathtub was found to be in good overall condition.It was fully function tested including attaching and detaching subchassis from seat frame.The locking latch on the lift arm was in good condition and the internal spring was very responsive without any clear issues.No malfunction was found.The chair detachment could have been only recreated when the chair frame did not fully engage the catch on bath¿s lift arm.In the course of our investigation, the customer facility staff reported that during incident, the caregiver had assumed that the chair was securely connected (as it was aligned with the lift arm), but did not physically check to see if the latch was closed securing the seat to the arm.Both involved caregivers were trained of the bath usage in february 2019.Malibu is intended for therapeutic bathing and showering of hospital or care facility residents under the supervision of trained skilled nursing staff in accordance with the instructions outlined in the operating and product care instructions.Please note that malibu/sovereign operating and product care instructions (opci; 04.Aj.00_2gb issued in (b)(6) 2004; active at the time this device was manufactured) includes information how to use the device and warnings related to bath handling relevant for the reported incident, such as: ¿before using the transfer chair, make sure it is safely attached to the lift arm and that the locking mechanism is thoroughly locked.¿ ¿before using the transfer chair always make sure that it is safely attached to the lift arm i.E.The safety catch is in its normal position.¿ ¿before transporting residents on the transfer chair with chassis always make sure that the transfer chair is safely attached to the chassis.¿ the opci also includes section related to correct connecting and disconnecting the transfer chair from the lift arm to the chassis, describing necessary steps together with supporting illustrations and warnings.As per the information received from the customer the resident was totally dependent on staff for all transfers and that sitting balance was not sufficient.In intended use section the opci informs user that: ¿to use the chair and chassis the resident needs to be able to sit in an upright position, normally defined as active or semi-active.¿ malibu can be used for handling of dependent patients, but additional equipment (the shower and robe table) is required.It can be used by wholly dependent residents when using a sling lift for transferring to and from.Based on the performed investigation the most probable cause of event is related to caregivers' omission of the safety catch check to confirm correct attachment of the chair to bath¿s lift arm hence it is considered a user error.In summary, the inspection of the device confirmed that it was according to the manufacturer¿s specification.According to the customer allegation, the chair detached from the lift arm and fell to the floor together with the patient.The bath 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 regulatory authorities due to indication of patient fall and 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: 9471943
• MDR Text Key: 198516437
• Report Number: 3007420694-2019-00223
• 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: 01/10/2020

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: AUL4335-GB
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/04/2019
• Initial Date FDA Received: 12/16/2019
• Supplement Dates Manufacturer Received: 12/04/2019
• Supplement Dates FDA Received: 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 77 YR
• Patient Weight: 63