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

Model Number AR32212-US

Device Problem Device Tipped Over (2589)

Patient Problem No Patient Involvement (2645)

Event Date 04/13/2016

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 arjohuntleigh representative that tub tipped over when filled with water.No residents were in tub at the time when incident occured.No staff or damages occurred.This tub was not installed by arjohuntleigh representative as tub was purchased second hand.The examination of the device showed the one leg's bolt was broken.

Manufacturer Narrative

An investigation was carried out into this complaint.When reviewing similar reportable events for system 2000 we have found a low number of other similar cases - tub tipped due to broken leg bolt.We have been able to establish that there is no complaint trend concerning these kind of events.The device was inspected by an arjohuntleigh representative at the customer site and found to be out of the specification - broken leg bolt.The device tipped over when filled with water and in that way contributed to the event.From received information no residents were in bath at the time when incident occurred.The root cause of this event appears to be lack of or poorly performed maintenance and wrong installation.Based on reviewing similar reportable events and information provided by arjohuntleigh representative we can conclude that: the bolts fastening the legs to the chassis of the bath can get loose and broken off.The bolt rests on a bushing inside the leg to unload it from the weight of the tub.For a bolt that is not positioned correctly inside the bushing this is the point where the load supplied to the leg is rapidly increased while load comes on it as the bath is being filled.All devices are equipped with instruction for use (ifu) which clearly inform how to safe use the device.Ifu for system 2000 contains information: - "the equipment must be installed according to the assembly and installation instructions, which can only be superseded by local code.The normal useful life of this equipment, unless otherwise stated, is ten (10) years, subject to required preventative maintenance as specified in the operating and daily maintenance instruction, the assembly and installation and the spare part instructions." section care and maintenance' included in instruction for use informs about recommended actions that should be taken to preserve device safety and performance.In accordance to it, user is obliged: - every week: examine the bath for cracks or other damage.- every month: check that all screws, bolts and other joints are perfectly tight.Device has been in use for over 14 years.Moreover idf contains information that "tub to look aged , rubber trim was loose".Information provided to complaint indicates that bath has not been installed by an arjohuntleigh authorized service technician.During bath examination our technician removed the damaged bolt and discovered that bath was not installed properly.In accordance to our investigation the root cause of this problem is a combination of: - installation error - bolts not correctly tightened during installation - not following recommendation in assembly and installation manual.- not following the ifu with regards to following the maintenance per preventive maintenance schedule (pms) and taking into account the intended device lifetime of 10 years.From above findings we conclude that this incident was caused by user error - the event occur due to not following the instruction for use by caregiver.Bath has not been install by arjohuntleigh authorized service technician.Device inspection confirm that the failure occurred due to wrong installation.Please note, that if caregiver would have followed every guideline given in instruction for use (including safety warnings and importance of performed preventive maintenance) 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: 5640234
• MDR Text Key: 44689633
• Report Number: 3007420694-2016-00085
• Device Sequence Number: 1
• Product Code: ILM
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 06/08/2016,04/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AR32212-US
• 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: 06/08/2016
• Distributor Facility Aware Date: 04/14/2016
• Device Age: 14 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 05/09/2016
• Initial Date Manufacturer Received: 04/14/2016
• Initial Date FDA Received: 05/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2001
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other