MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. MALIBU; ILJ

Model Number AJL7111-GB

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problems Bruise/Contusion (1754); Fall (1848); Head Injury (1879)

Event Date 07/24/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This appears to be a "malfunction" type of event not because there was a technical malfunction of the device, but since due to a use error the device did not perform as intended.An investigation was carried out into this complaint.When reviewing similar events for malibu/sovereign we have found low number of other similar cases where seat detached from a lifting unit.We have been able to establish that there is a decreasing occurrence rate for these kind of events in last 5 years.The device was inspected by an arjohuntleigh representative at the customer site and found to be working to its specification - no fault was found that could contribute to reported incident.The device was being used for patient handling and in that way contributed to the event.Due to the information and suggestion made from the service technician who could not re-create the reported event and no malfunction was found, it is most likely that problem was caused by user error - not following warnings included in instruction for use.The chair is attached to the lift arm and secured by the locking mechanism.There are 3 main potential factors that can be considered to lead to detachment of a seat: lifting mechanism was faulty and not allowing to seat to be correctly attached to the lifting arm - this is not related as no malfunction was found in locking catch and it was not possible to re-create this event.There was an obstruction near the seat and while lowering, seat hit an obstacle and was pushed upward, this possibility is supported by not correctly functioning locking mechanism - same situation like in first factor, additionally as confirmed during device examination, there were toilet and wash hand basin but nowhere in the way of the bath, therefore we find this to be not related.Seat wasn't correctly attached to the lifting mechanism by the user - this factor seems to be most related and suggested by the service technician who examined the involved device: "i cannot replicate this event and i cannot see how this chair frame became disengaged unless the staff have not made sure the clip and hook were in the correct position before the lifted the unit off the chassis." from the above evaluation the cause for the seat to detach that fits best with the event description and findings, appears to be that it wasn't correctly secured to the locking mechanism and it's attachment wasn't checked.Product instruction for use is attached with each device.Ifu (04.Au.02/3gb) informs how to correct and safe use the device.It warns: "before using the transfer chair, make sure it is safely attached to the lift arm and that the locking mechanism is thoroughly locked." "when using the lift arm with transfer chair the operator must insure that there are no obstructions or persons in the immediate vicinity that could impede its movement.Make sure that the residents hands and feet are placed on the appropriate rests.Failure to heed these safety precautions may result in severe injury to the persons involved or to the equipment." ifu also informs that user must make sure that: "all lifting/transporting equipment is in good condition, follow the instructions for all equipment." instruction for use provides also procedure of correct and safe use of the device, including "connecting/disconnecting the transfer chair to the lift arm" where additionally warns: "warning! before using the transfer chair always make sure that it is safely attached to the lift arm!" the most possible cause why didn't caregivers follow recommendations included in instruction for use is insufficient or lack of training as no details regarding training to involved staff were provided.Therefore it can be recommended to re-train users in device handling with indication of part designation, product description and safety warnings.The received information and our evaluation as described above are showing that if malibu's warnings were followed in accordance to ifu, there would be no patient or caregiver at risk.

Event Description

Initially it was reported by arjohuntleigh representative that a seat detached from the lifting unit while lowering the patient."caring staff had transferred the client onto the chair assembly and were about to engage this onto the bath frame, they clipped the unit into the arm assembly and started to raise the chair, released the transport chassis and raised the chair higher when all of a sudden the chair dis-engaged and the client and chair fell to the floor, the staff quickly lifted the client back onto a seating position and reassured before calling an ambulance as a safety precaution." from the received information bruised side and bump on the head occurred to the resident as a result of this incident.The resident was dis-charged after being submitted and observed.

• Brand Name: MALIBU
• Type of Device: ILJ
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 5020686
• MDR Text Key: 23705810
• Report Number: 3007420694-2015-00165
• 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: Notification
• Report Date: 08/21/2015,07/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Caregivers
• Device Model Number: AJL7111-GB
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/21/2015
• Device Age: 12 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 08/21/2015
• Date Manufacturer Received: 07/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2003
• 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