MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. MALIBU/SOVEREIGN (INCL. DIGNITY); BATH, HYDRO-MASSAGE

Model Number AZ6L20641

Device Problem Device Tipped Over (2589)

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

Event Date 05/24/2022

Event Type  malfunction  

Manufacturer Narrative

An inspection of the malibu bath performed by an arjo representative revealed two problems: the floor was damaged (fasteners were not secure), and the location of the bracket mounted was incorrect.As a result, the tub could tilt.According to the arjo representative, all corrections have been made and full functionality of the tub has been restored.The investigation is ongoing and further information will be provided upon conclusion of the investigation.

Event Description

Arjo was notified of an event involving a malibu bath.It was reported that during the first time using the bath while a resident was being lifted in the chair a staff noticed that the bath was not bolted to the floor.The staff member had to sit on the side of the bath and counteract the weight and balance the bath.No injuries were reported.

Manufacturer Narrative

Arjo was notified of an event involving a malibu bath.It was reported that during the first time using the bath, while a resident was being lifted in the chair, a staff noticed that the bath was not bolted to the floor.The staff member had to sit on the side of the bath and counteract the weight and balance the bath.No injuries were reported.The involved device was evaluated by an arjo representative.According to the results of the inspection and photo evidence provided, the wrong fixture was used in the wrong corner of the bath, and the fixings were also pulled out of the ground.Additionally, the floor at the customer site was found damaged.Following the malibu instructions for use (ifu; 04.Az6.00_4), the bath must be installed by appropriately trained personnel according to the assembly and installation instructions (06.Az6.00_1).This manual provides instructions (together with supporting graphics) 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 bathtub.The floor construction must be suitable for anchoring the fasteners¿ ¿when the work is completed check that: (¿) all details are mounted corresponding to the assembly instructions.¿.Additionally, to confirm that malibu/sovereign bathtub is correctly installed after the bathtub is fixed to a building structure the load test is performed on the transfer chair positioned outside of the tub.Following the installation manual: "maintain the test load of 195 kg for a minimum of 20 minutes.Remove the load.Verify the fastening by pulling the lift.Make sure the brackets aren't moving and that they are securely fastened on the floor.Inspect the floor fastening for cracks and deformations.Perform functionality test of the product".The ifu in the section "site preparation" includes the following information: "prior to installation of the malibu/sovereign bathtub the floor and walls within the required area must be finished." ¿care and maintenance¿ includes also 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.¿.Based on the performed analysis, it is likely the cause of the event was an incorrectly installed floor fixture and a damaged floor, which allowed the tub to move out of the required position.In summary, according to the gathered information the involved malibu bath was used for resident handling at the time of the event.Based on the performed evaluation of the device, it was incorrectly installed and tipped, so was not according to the manufacturer¿s specification.This complaint was decided to be reported to the regulatory authorities in abundance of caution due to indication of malfunction, which may lead to the resident fall and result in an injury occurrence.

• Brand Name: MALIBU/SOVEREIGN (INCL. DIGNITY)
• Type of Device: BATH, HYDRO-MASSAGE
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• Manufacturer Contact: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 14788507
• MDR Text Key: 302957480
• Report Number: 3007420694-2022-00097
• Device Sequence Number: 1
• Product Code: ILJ
• UDI-Device Identifier: 05056097365657
• UDI-Public: (01)05056097365657(11)220308
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/22/2022

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: AZ6L20641
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/25/2022
• Initial Date FDA Received: 06/23/2022
• Supplement Dates Manufacturer Received: 05/25/2022
• Supplement Dates FDA Received: 07/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female