MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB MALIBU/SOVEREIGN; BATH, HYDRO-MASSAGE

Model Number AZL23110-GB

Device Problem Device Tipped Over (2589)

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

Event Date 06/28/2023

Event Type  malfunction  

Event Description

Arjo was notified of an event involving a malibu bath.It was reported that the bath is not secured to floor and was tilting while a seat was being operated.It was stated that the floor on which the bathtub was placed had deteriorated to the level that the floor fixtures did not work.No patient involvement and no injuries were reported.

Manufacturer Narrative

The investigation is ongoing and further information will be provided upon conclusion of the investigation.

Manufacturer Narrative

Process of analyzing information is ongoing.Additional information will be provided upon conclusion of the investigation.

Manufacturer Narrative

Arjo was notified of an event involving a malibu bath.It was reported that the bath was not secured to floor and was tilting while a seat was being operated.It was stated that the floor on which the bathtub was placed had deteriorated to the level that the floor fixtures did not work.No patient involvement and no injuries were reported.According to the results of the device inspection and video evidence provided the bath attachment had been torn out of the floor.The floor at the customer's site was damaged.Therefore, it is likely the cause of the event was the damaged floor, which allowed the bath to move out of the required position.The malibu instruction for use (04.Az.00_8gb) in the section ¿care and prevetive maintenance¿ 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 ifu in the section "preparations" includes the following information: "floor attachments: the floor construction must be suitable for anchoring the bolts." "actions before every use (.) 2.Check bath and accessories for damage.3 if any part is missing or damaged - do not use the product." in summary, the bath detached from the floor and from that perspective, the device did not perform as intended.The malibu bath was not used for a patient handling at the time of the event.This complaint was decided to be reported to competent authorities due to indication of malfunction (bath not secured to the floor), which may lead to the patient fall and result in an injury occurrence.

• Brand Name: MALIBU/SOVEREIGN
• Type of Device: BATH, HYDRO-MASSAGE
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov 24121 ; SW 24121
• Manufacturer (Section G): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov 24121 ; SW 24121
• Manufacturer Contact: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 17404236
• MDR Text Key: 320149725
• Report Number: 3007420694-2023-00180
• Device Sequence Number: 1
• Product Code: ILJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/21/2023

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: AZL23110-GB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/28/2023
• Initial Date FDA Received: 07/27/2023
• Supplement Dates Manufacturer Received: 06/28/2023; 06/28/2023
• Supplement Dates FDA Received: 08/24/2023; 09/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2012
• 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