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

Model Number AJL13341-GB

Device Problem Detachment Of Device Component (1104)

Patient Problem Fall (1848)

Event Date 05/16/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).An investigation was carried out into this complaint.When reviewing similar reportable events for malibu we have found other similar cases where the chair did not securely attach to the lifting arm.We have been able to establish that there is no complaint trend concerning these kinds of events.The patient was being transferred to the bathroom using a bath chair and a transfer trolley.After being cleaned up post commode the seat was moved into position to begin lift into bath.The hand control was used to raise the chair.On attempting to remove the transfer trolley, the patient and the chair frame fell to the floor and in that way contributed to the event.No injury occurred.The device has been tested by technician - function test showed that the device was working to its specification.No repair or adjustment has been done.An arjohuntleigh technician tested bath function focusing on transfer procedure.The seat has been moved up to lift arm using hand control.The handset was used to raise chair frame until the latch was correctly located.The transfer trolley was removed and transfer into the bath- test was completed without problems (test was performed with and without load).No malfunctions were found that could have caused or contributed to the event.The product's instruction for use is attached with each device, ifu includes information how to properly and safely use the device: "always make sure that: all lifting/transporting equipment is in good condition, follow the instructions for all equipment; chair seats, shower tables etc., are fastened and all screws tightened; the wheels always are locked during resident handling, except during transportation".The instruction for use also includes warnings concerning the locking mechanism of the lifting unit and seat and transferring chair: "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 and/or using the height adjustable bathtub, the operator must assure that there are no obstructions or persons in the immediate vicinity that could impede its movement.".Moreover the ifu provides instructions how to properly connect chair to the lifting unit: "connecting: set the bath tub in its lowest position by press and hold the lowering of tub button; press lift out of tub; grip the transfer chair and place the attachment of the chair and hook up the chair to the lift arm; raise the lift arm by press the hold the lift into tub button, do that the transfer chair is hooked up on the lift arm and the chassis gets clear of the floor; make sure that hooks (a) are securely attached to the lift arm and that the safety catch (b) is in place.Also the ifu contains the warning: "before transporting residents on the transfer chair with chassis always make sure that the transfer chair is safely attached to the chassis i.E.That the spring loaded catch has clicked into its locked position." information provided in the complaint indicates that the chair failed to be securely attached onto the lifting arm hook.The bath and transfer trolley have been tested and no failure was found.There was no possibility to recreate the event.The bath was in good working condition.According to the above the bath was found to have been to specification when the event took a place.It can be established that bath was being used for patient handling but it appears it contributed to the event likely due to a use error.Please note, 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.

Event Description

There was initially reported to arjohuntleigh representative that:."patient was being transfer to bathroom using bath chair and transfer trolley.After being cleaned up post commode the seat was moved into position to begin lift into bath.The hand control was used to raise the chair.On attempting to remove the transfer trolley, the patient and the chair frame fell to the floor.No severe injuries reported.".

• Brand Name: MALIBU
• Type of Device: ILM
• 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: 5725423
• MDR Text Key: 47396352
• Report Number: 3007420694-2016-00112
• Device Sequence Number: 1
• Product Code: ILM
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 06/15/2016,05/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AJL13341-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: 06/15/2016
• Distributor Facility Aware Date: 05/17/2016
• Device Age: 8 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 06/15/2016
• Date Manufacturer Received: 05/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2007
• 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 Age: 80 YR
• Patient Weight: 43