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

Model Number AR31211-EU

Device Problem Leak/Splash (1354)

Patient Problem Fall (1848)

Event Type  malfunction  

Manufacturer Narrative

This report is being filed under (b)(4) by arjohuntleigh (b)(4) on behalf of the importer arjohuntleigh, inc.(ahus) (b)(4).Additional information will be provided following the conclusion of the investigation.

Event Description

Initially it was reported to arjohuntleigh representative that "we was informed today that due to shower handle leakage, water felt on the floor then patient has fallen.".

Manufacturer Narrative

An investigation was carried out into this complaint.When reviewing similar reportable events on system 2000 baths we haven't found any other similar case.Therefore we consider this event to be isolated incident.The device was inspected by an arjohuntleigh representative at the customer site and found to be not working to its specification.Water was leaking from the bath due to a defective solenoid valve.The device was being used by the caregiver at the time of the incident, however the exact circumstances of the event remain unknown as the customer did not reveal detailed incident description.The valve has been replaced which solved the water leak.The bath has been in use since (b)(6) 2005 and the customer never performed service (no contract, no preventive maintenance) which is against the intended use and likely to have caused the issue; we came to a conclusion that the reported problem - caregiver slipped because of wet floor, is the most likely related to user error.Product instruction for use (ifu) is equipped with each device.Ifu provides information about correct and safe use of the product.It informs: "a service routine has to be done on your system 2000 to ensure the safety and operating procedures of your product.See chapter care and preventative maintenance.If you require further information, please contact arjohuntleigh for comprehensive support and service programs to maximize the long-term safety, reliability and value of the product.Contact arjohuntleigh for replacement parts.Contact information appears on the last page of this instructions for use (ifu)." also instruction for use provides information about preventive maintenance actions.In accordance to it customer is obliged to check visually hoses, pipes and connections every week - inspect for leaks of any kind.From above labeling excerpts we can state that the user did not follow ifu's recommendations.Please note also 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 it by itself, but these kind 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 caregiver has never performed bath service and check bath condition.Therefore we also consider this event to be isolated incident where user wasn't care enough to avoid this incident.

• Brand Name: SYSTEM 2000
• 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: 5491574
• MDR Text Key: 40029381
• Report Number: 3007420694-2016-00030
• Device Sequence Number: 1
• Product Code: ILJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 04/15/2016,02/16/2016

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: AR31211-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: 04/15/2016
• Distributor Facility Aware Date: 02/17/2016
• Device Age: 11 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/15/2016
• Initial Date Manufacturer Received: 02/17/2016
• Initial Date FDA Received: 03/10/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2005
• 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