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

Model Number AZR23110-GB

Device Problem Component Falling (1105)

Patient Problems Fall (1848); No Consequences Or Impact To Patient (2199)

Event Date 04/20/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information will be provided upon conclusion of the manufacturer's investigation.

Event Description

Arjohuntleigh was informed about a customer complaint related with malibu bath.It was indicated that during fitting the bath seat on the lift arm for entering the bath, the chair became detached which caused the resident to fall to the floor.Fortunately, no injury was sustained.

Manufacturer Narrative

This report is being filed under exemption e2012070 (b)(4).An investigation was carried out into this complaint.Malibu bath is intended for therapeutic bathing and showering of care adult residents, designed especially for hospitals, nursing homes and other health care uses.Arjohuntleigh was notified about an incident with malibu/sovereign on 2017-05-16.It was reported that when attempting to attach the chair to the lifting arm, the chair failed to locked into the attachment mechanism of the lift arm what possibly remained unnoticed by caregiver.As a result, the resident fell from the seat while the chassis was pulled from the chair fixture.No injury was sustained, no adverse event occurred.After the incident the device was inspected by arjohuntleigh representative and no fault has been found.The device was in general good condition with signs of use.Neither dents nor paint damage were identified.The functional test performed did not reveal any anomalies, safety catch on lifting arm was in perfect working condition.When reviewing reportable events for malibu device, we have found limited number of other cases where the chair was not securely attached to the lifting arm.We have been able to establish that there is no complaint trend concerning this kind of events.Product instruction for use (ifu 04.Az.00/12 gb dated on january 2015), which is delivered with each device, includes information how to properly and safely use the device.Before every use a user shall check that all parts are in place, there is no damage or missing parts (ifu, p.7)."to avoid the patient from falling out of the device, make sure that all catches are in a locked position".Also, the graphic in ifu shows how to attach chair to the lifting arm.(ifu, p.18)."to avoid the patient from falling out of the device, make sure that all catches are in locked position" (ifu, p.20)."place the transfer chair to the attachment of the lift arm and hook up the transfer chair" (ifu, p.20).Also, the graphics in ifu show how to attach chair to the lifting arm.(ifu, p.24).Ifu indicates caregiver obligations during utilizing the device, which include visual check of mechanical attachments.This involve checking if no screws or nuts are loose, if there is no gaps, if safety catch and transfer chair attachment is easily moveable, checking the lifting hook attachment.A functional tests include checking, inter alia, if lift arm moves correctly (ifu, p.38 and 39).The indication in the complaint was that the chair catches failed to lock into the attachment mechanism of the lift arm.The bath and transfer trolley have been tested and no failure was found.The above would suggest that the most likely root cause of the issue is related to the user not following recommendations in product instruction for use.It could happen that the chair was attached to the lift with handle or part of a chair frame not design for this purpose.Please note that the chair has only one part, a pivot, that is used to secure the chair in the attachment (hook) of the lift arm.When a chair is placed in the hook, the chair weight lowers the catch, which then snap back into place locking the chair in the lift proving that the attachment is made correctly.It needs to be emphasized that if the caregiver follows every guideline given in instruction for use, there is a really low possibility of any potentially risky situation to occur.In conclusion, although no technical failure of the bath was found during on-side inspection by arjohuntleigh representative, the device transfer chair was reported to be separated from the lifting arm and from that perspective, the bathing system did not meet its performance specification.It was used for patient's care and this way contributed to alleged event.Although there was no injury reported, due to the nature of this incident we are reporting this event to competent authorities due to the potential of harm with a high severity.

• Brand Name: MALIBU
• Type of Device: BATH, HYDRO-MASSAGE
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov, 24121 , SW; SW 24121, SW
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer Contact: kinga stolinska ; verkstadsvagen 5; komorniki, 24121-, SW ; SW 24121, SW ; 98282467
• MDR Report Key: 6633000
• MDR Text Key: 77649087
• Report Number: 3007420694-2017-00142
• 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: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Model Number: AZR23110-GB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/11/2017
• Distributor Facility Aware Date: 05/16/2017
• Device Age: 5 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 07/11/2017
• Date Manufacturer Received: 05/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2012
• 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