MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. SYSTEM 2000; ILM

Model Number AP32311-EU

Device Problem Device Tipped Over (2589)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/20/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was initially reported to arjohunteigh representative that: "client was in bath, bath was filled to highest level.Bath seems to move to one side, water flows over, client was in it, bath moved back to its position.".

Manufacturer Narrative

An investigation was carried out into this complaint.When reviewing similar reportable events for system 2000 we have found a very low number of other similar cases - tub was tipping during use.The device was being used for the patient therapy.The bath was filled to highest level and seems to move to one side, water flows over, bath moved back to its position- in that way it contributed to the event.The described problem occurred only once and information provided in incident description form (idf) suggest that device was in good working condition and all functions work as intended.The technicians try to recreate the event.Several actions were made to try to simulate the situation again.Without positive result.Technicians checked bath configuration, length chassis and bath, that was correct.The only situation which was simulated and confirm customer statement was when the bath was filled till maximum level (few cm under the top bath tub) and technicians placed 85 kg weight on the end of the bath.Then one leg become loose from the floor.All devices are equipped with instruction for use (ifu) which clearly inform how to correctly use and maintenance the product.Ifu for system 2000 (04.Ar.09) once a week caregiver should: "visually check hoses, pipes and connections.Visually inspect for leaks of any kind by looking under tub, lid behind the panel." equilibrium calculation has been establish on system 2000 tubs and included in test report (b)(4) dated on 2007-04-04.An equilibrium calculation on the three models 20, 23 and 25 was made to investigate the risk of the tub tipping over.The criteria was that a person weighing 182kg should be able to stand in a tub filled with water at the position where the back slope begins without any risk for the tub to tip over.The calculations shows that all the models reach the set criteria.Calculations are made to verify the strain that the tub expose on the floor.From this we can conclude that it is not likely that tub legs could raise by itself during normal use of the product.From all of above information we could not determine the exact root cause of the failure.It can be established that the bath was being used for patient handling but it appears that the device was according to specification when the event occurred.The device was in good working condition.Therefore the device played a role in the event but not as result of a malfunction.Moreover technicians managed to recreate the event only situation when bath was fill to maximum level and all weight was placed on the end of the bath.Please note, that if caregiver would have followed every guideline given in instruction for use there would have been no user at risk.

• Brand Name: SYSTEM 2000
• 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: 5731803
• MDR Text Key: 47597670
• Report Number: 3007420694-2016-00113
• Device Sequence Number: 1
• Product Code: ILM
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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
• Type of Report: Initial,Followup
• Report Date: 08/05/2016,05/20/2016

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?: No
• Device Operator: No Information
• Device Model Number: AP32311-EU
• 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: 08/05/2016
• Distributor Facility Aware Date: 05/20/2016
• Device Age: 6 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 06/17/2016
• Initial Date Manufacturer Received: 05/20/2016
• Initial Date FDA Received: 06/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2010
• 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: 70