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

Model Number AZR23110-GB

Device Problem Device Tipped Over (2589)

Patient Problems Bruise/Contusion (1754); Tissue Damage (2104)

Event Date 07/10/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The involved bathtub was evaluated by the qualified arjo representative.According to results of inspection, the bath was insufficiently secured to the floor with only one fixing in place when two should be used.This caused the floor attachment to be ineffective and resulted in the bracket not fully securing the leg of the bath to the floor.Additional information will be provided upon conclusion of the investigation.

Event Description

Arjo was notified about an event with involvement of malibu bathtub.It was reported that at the conclusion of a bathing session the resident was being removed from the bath.The bath's seat was raised, turned and lowered to allow the bather to alight from the seat.As the bather maneuvered towards the edge of the seat the whole bath tilted slightly to the side of the seat then rectified itself without any further issues.The bather was removed from the seat and the bath was removed from use.The patient sustained bruising and soft tissue damage to the lower part of both legs and the nursing staff applied a treatment.

Manufacturer Narrative

Arjo was notified about an event with involvement of malibu bathtub.It was reported that at the end of a bathing session, the resident was being removed from the bath.The bath's seat was raised, turned and lowered to allow the bather to alight from the seat.As the bather maneuvered towards the edge of the seat, the whole bath tilted slightly to the side of the seat, but then rectified itself without any further issues.The resident was safely removed from the seat and the bath was removed from use.The patient sustained bruising and soft tissue damage to the lower part of both legs and the nursing staff applied a treatment.The involved bathtub was evaluated by the qualified arjo representative.According to results of inspection, the bath was insufficiently secured to the floor with only one fixing in place when two should be used.This caused the floor attachment to be ineffective and resulted in the bracket not fully securing the leg of the bath to the floor.The device history records available for arjo were reviewed.It was confirmed that the bath had not been on service contract within last 7 years.The last reference in arjo records regarding this bathtub was registered in 2011.No further records of service carried out on this device were made available.Based on the collected information the bath in question was maintained by the 3rd party and under the customer's responsibility.This malibu/sovereign equipment is intended for therapeutic bathing and showering of care adult residents under the supervision of trained caregivers with adequate knowledge of the care environment, its common practices and procedures, and in accordance with the guidelines in the operating and product care instructions.Anyone using this equipment must also have read and understood the instructions in the manual.This equipment must be used in accordance with these safety instructions.Please note that procedure for correct performance of an assisted bathing is presented in the operating and product care instructions (ifu; 04.Az.00_2 dated on april 2008).According to ifu the equipment must be installed by appropriately trained personnel according to the assembly and installation instructions (06.Az.00_1 issued in april 2008).This manual provides instructions regarding correct installation of floor fixtures and includes the following information reminding the need to use floor attachments: "to prevent the bath tub from falling over, the floor fixtures provided in the installation kit must be used when installing malibu/sovereign.The floor construction must be suitable for anchoring the bolts." "when the work is completed check that: all details are mounted corresponding to the assembly instructions." moreover, to confirm that malibu/sovereign bathtub is correctly installed after the bathtub is fixed to a building structure the load test should be performed on the transfer chair positioned outside of the tub.Following the installation manual the weight of the applied test load (according to the maximum lifting capacity of the lift arm) should be 195kg (430 lbs) maintained on the bath chair for a minimum of 20 minutes.The bathtub should also be levelled by tightening the foot nuts against the floor fixtures.Please note that section "care and maintenance" of the ifu includes the caregiver obligations, inter alia the one related to the mechanical attachments such as floor fixtures to be checked on a weekly basis: "check mechanical attachments: check that all screws and nuts are tightened and that there are no gaps." the check of the malibu floor fixtures mounting also comes under the annual preventive maintenance schedule for malibu/sovereign described in the ifu and in details in maintenance and repair manual (09.Az.03_4 dated on august 2015).It requires to check mechanical attachments including tub foots and floor attachment.These actions must be carried out by qualified personnel, using correct tools and knowledge of procedures.It should be underlined that if installation requirements are followed and the bathtub is secured according to the operating and installation manuals the similar event is unlikely to occur and there would be no patient or caregiver at risk.Based on the performed analysis, it is likely the main cause of the event was lack of proper preventive maintenance such as regular checks and annual service that most likely would detect the wrong bathtub installation (only one of two floor attachment was used).Arjo is not in possession of the service history records for this specific bathtub as it was not serviced by arjo for last 7 years.It is not possible to determine why only one floor fixture was mounted.In summary, according to the gathered information the involved malibu bath was used for patient handling at the time of the event.Based on the performed evaluation of the device, it was incorrectly installed, so was not according to the manufacturer's specification.The complaint was decided to be reported due to risk of harm occurrence for a patient or caregiver posed by bath tilt or tip over.No adverse health consequences occurred.

• 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: 8863645
• MDR Text Key: 199112667
• Report Number: 3007420694-2019-00126
• 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: 09/04/2019

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
• Initial Date Manufacturer Received: 07/10/2019
• Initial Date FDA Received: 08/06/2019
• Supplement Dates Manufacturer Received: 07/10/2019
• Supplement Dates FDA Received: 09/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 62