MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB MALIBU/SOVEREIGN (INCL. DIGNITY); BATH, HYDRO-MASSAGE

Model Number AJR1334-GB

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Fall (1848)

Event Type  malfunction  

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 detached from lifting arm with a resident on it and fell to the floor.No injury was reported.

Manufacturer Narrative

The involved device was taken out of use and evaluated by the arjo representative.The investigation is on-going and further information will be provided in the next report.

Manufacturer Narrative

Arjo was notified about an event with involvement of malibu bath.It was initially reported that the bath was very noisy and then dropped to the floor.During the arjo representative visit at the customer facility the event scenario was clarified.There was no bath noise and drop but the bath¿s integrated transfer chair detached from the lifting arm with resident on it and fell to the floor.No injury was reported.The malibu bath was evaluated by the arjo representative and it was found to be in good overall condition.The connection of the integrated chair with lifting arm was working properly.No signs of damage to the seat or sub chassis were found.The inspection of the product confirmed that the bath was operating properly.The event was not recreated.The arjo representative suggested that the chair might not have been properly attached.Looking at the product inspection results (no faults found) and post market surveillance data, we came to the conclusion that the incorrect attachment of the chair was the most probable cause of the event, which is in line with the arjo representative suggestion.The malibu operating and product care instructions (opci) includes information on how to use the device and warnings related to bath handling relevant for the reported incident: ¿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.¿.The opci also includes supporting illustrations presenting how to connect the transfer chair to the lift arm and disconnect the transfer chair from the lift arm.Based on the performed investigation the most probable cause of event is related to the chair not attached to bath¿s lift arm.In summary, no technical failure of the bath was found during inspection by arjo technician.The device transfer chair was reported to separate from the lifting arm, most likely because it was not attached to the lifting arm, and therefore from this perspective, the bathing system did not meet the performance specification.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 which could contributed to an injury occurrence.

• Brand Name: MALIBU/SOVEREIGN (INCL. DIGNITY)
• 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: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 14870866
• MDR Text Key: 303326935
• Report Number: 3007420694-2022-00102
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/29/2022

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: AJR1334-GB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/13/2022
• Initial Date FDA Received: 06/30/2022
• Supplement Dates Manufacturer Received: 06/13/2022
• Supplement Dates FDA Received: 07/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2008
• 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
• Patient Weight: 44 KG