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

Model Number AZL23100-GB

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Skin Tears (2516)

Event Date 07/12/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information will be provided following the conclusion of the investigation.

Event Description

On (b)(6) 2019 arjo was notified about the incident with the involvement of malibu bathing system.It was stated that while transfer chair was being raised to remove wheel chassis, chair with patient on it tipped to the left side and became detached from the lift arm.Immediately after noticing the failure nursing staff caught the chair and lowered resident back to the floor.As the consequence of the event resident sustained cut on the face below left eye which was assessed as not serious.

Manufacturer Narrative

On 2019-jul-18 arjo was notified about an incident with malibu/sovereign bathing system.It was stated that when raising the bath's transfer chair with commode seat from the floor, it failed to lock into the attachment mechanism of the bath's lift arm.While disengaging the transfer chair from the wheel chassis, the detachable chair disconnected from the lifting arm and tilted to the left side.Following information reported by the nursing staff, immediately after noticing the failure of locking the transfer chair catches to the lifting arm , the chair has been caught and lowered back to the floor.There was no patient fall reported.However, the resident sustained cut on the face as the consequence of hitting nursing staff arm.Malibu/sovereign bath is intended for therapeutic bathing and showering of care adult residents, designed especially for hospitals, nursing homes and other health care uses.After the event the device was inspected by arjo qualified representative.No fault nor deficiencies were noted, the device was working as intended.It was also mentioned that date of last device service was on 2019-mar-29, provided by the 3rd party service provider.Product instructions for use (ifu 04.Az.00_2gb, april 2008), which is delivered with each arjo device, includes information and pictures how to properly and safely use the device and secure transfer chair onto the lifting arm: "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)." "place the transfer chair to the attachment of the lift arm and hook up the transfer chair." "always use the safely belt when someone is seated in the transfer chair due to risk of fall or other dangerous situations." "continuing to use this product without conducting regular inspections or continuing to use this product when a fault is found will seriously compromise the user and residents safety." 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.(ifu, p.27 and 28).Taking into account all information gathered the main contributing factor that might have led to this particular event cannot be indicate with a certainty.However, there was no product malfunction, safety catch mechanism worked as intended so it may be possible that caregivers did not follow all recommendations provided in product instruction for use and did not ensure that the catch locked in place when the chair was being lifted.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 lifting 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 instructions 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 inspection by arjo technician, 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.We decided to report this even to the competent authorities due to fact that during lifting process chair detached from a lifting arm and such circumstances may result in serious injury upon reoccurrence.

• 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: 8892250
• MDR Text Key: 198630457
• Report Number: 3007420694-2019-00135
• 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: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AZL23100-GB
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 101 YR