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

Model Number AZR23116-GB

Device Problems Leak/Splash (1354); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problems Bruise/Contusion (1754); Fall (1848)

Event Date 12/07/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Initially it was reported to arjohuntleigh representative that caregiver slipped outside of the bath due lo leak from the drain pipe: "resident slipped on floor and fell over, the floor was made wet by a leaking drain pipe on the malibu bath".The injured caregiver sustained bruising to right arm.No medical intervention was required.The bath was leaking due to a poorly routed drain pipe which was crushed every time the bath was raised/lowered eventually causing the pipe to leak.

Manufacturer Narrative

(b)(4).An investigation was carried out into this complaint.When reviewing similar reportable events on malibu baths we haven't found any other similar cases.We consider this event to be isolated incident.The device was inspected by an arjohuntleigh representative at the customer site and found to be out of its specification - broken panel and leaking drain pipe.The device was being used for patient handling and in that way contributed to the reported event - slippage of the user.The received information showed that the resident slipped while exiting the bath.It was stated that the floor was made wet due to a leaking drain.The further examination showed that the drain was leaking due to a poorly routed pipe which was also crushed by the base panel while the bath was raised or lowered.There are 2 main possible causes for this situation: 'incorrect installation' and 'incorrect or lack of maintenance'.The first factor can be excluded as the bath was in use for about 5 years and there was no information about any re-installation taking place.Product instruction for use (ifu) is equipped with each device.Ifu (operating and product care instructions 04.Az.00_2gb from april 2008) provides information about correct and safe use of the product.'care and maintenance' section included in it informs: "the malibu/sovereign is subject to wear and tear, and the following actions must be performed when specified to ensure that the product remains within its original manufacturing specification" preventive maintenance includes inter alia the following actions: - visually check all exposed parts - every week: "especially parts in contact with resident or caregiver.Make sure that no cracks or sharp edges could cause injury or become unhygienic" - visually check hoses, pipes and connections - every week: "visually inspect for leaks of any kind by looking under the tub".The received information showed that: a) last maintenance was performed in june 2015 however no leakage was noticed at that time.B) after the maintenance, the customer made a service call, however not because of leaking drain, but for a panel - quote for the damaged panel replacement.There was no information about the leaking drain pipe.C) damaged panel (loose) trapped the pipe what resulted in a breakage and leakage d) broken pipe was reported after the incident.The above information confirms that the customer was aware about the failures with this bath - the device failed to meet its specification.However as presented above, the involved device was still in use and in that way contributed to the reported event.Instruction for use informs: "if the product does not work as intended, immediately contact your local arjo representative for support" the customer acted in line with the above recommendation, however since they were aware about the problem, the bath should have either be taken out of the use or special precautions should have been taken when using the bath.Please note also that we consider that slippage is a sudden or involuntary movement where the person lose foothold, as on a smooth surface.The leakage of the water doesn't cause such situation by itself, but these kinds of events are considered to be unfortunate accidents.There are also other factors that need to appear to cause this incident e.G.: lack of carefulness, smooth or soapy surface.Problem described in complaint (b)(4) concerns situation where the customer was aware about problem with a bath - broken panel, but the device was still in use.The quotation was provided to the customer, but not accepted before the reported event took place.From our evaluation we consider this event to be isolated incident where user wasn't care enough to avoid this incident.

• 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: 5317490
• MDR Text Key: 34086396
• Report Number: 3007420694-2015-00242
• 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: Repair
• Type of Report: Initial,Followup
• Report Date: 01/19/2016,12/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Model Number: AZR23116-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: 01/19/2016
• Distributor Facility Aware Date: 12/09/2015
• Device Age: 5 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 12/22/2015
• Initial Date Manufacturer Received: 12/09/2015
• Initial Date FDA Received: 12/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2010
• 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 Weight: 75