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

Model Number AR*

Device Problems Break (1069); Device Tipped Over (2589); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/20/2015

Event Type  malfunction  

Event Description

It was initially reported by arjohuntleigh representative that tub tipped: the staff were filling the tub for a resident and it suddenly collapsed, dumping water everywhere flooding the room and hallway.The left leg had given out causing the hinge to drop on one side.No one was in the tub at the time, but the resident was sitting beside the tub ready to be bathed.The rear mounting bolt for the left leg was sheared off causing the failure.No injury occurred as a result of this incident.Photos provided with this complaint confirmed sheared off leg bolt.Device examination performed with the customer showed that general condition of the unit is good with no visible damage.As per the service technician: "complete visual inspection of unit with no apparent reason why the left rear leg bolt has sheared off.No other damage to the unit that can be seen." dates of the last maintenance and training to the staff are unknown as the device is not under arjo's service contract.

Manufacturer Narrative

(b)(4).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.Please note that arjohuntleigh manufactured over (b)(4) system 2000 baths to date.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 was being used for patient handling - patient was preparing for a bath, and in that way contributed to the event.From received information no injury occurred to the patient as a result of this incident.The root cause of this event appears to be lack or poor maintenance.Information provided by arjohuntleigh representative showed that this event is related to the issue of corrective and preventive action capa (b)(4) - loose leg bolts: the bolts fastening the legs to the chassis of the bath can get loose and broken off (different applied load and tensions during filling the bath).The bolt rests on a bushing inside the leg to unload it from the weight of the tub.It appears that the bolt tend to break during the filling procedure of the bath.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.In accordance to capa's 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 carrying out the maintenance according to preventive maintenance schedule (pms).The review of other similar complaints concerning loose bolts and investigation for corrective and preventive action - capa1126, showed that the root causes for these kind of events are: incorrect installation - not related to complaint tw518680 because the involved device was in use for about 14 years and there is no indication that this bath was re-installed by the customer.Poor maintenance - not following recommendations included in instruction for use.This factor is most likely to be related: device was not under arjo's service contract, no service records are available, the customer was not informed about tan see201304 as this is document for arjo's engineers only.From the above findings we conclude that this incident was caused by user error - poor or lack of maintenance what is in line with ours conclusions for previous similar complaints.The received information and our evaluation as described above are showing that if system 2000's preventive maintenance was followed in accordance to product documentation, there would be no patient or caregiver at risk.See scanned page.

• Brand Name: SYSTEM 2000
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z.O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-6 2052; PL PL-62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z.O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PS-6 2052; PL PS-62052
• Manufacturer Contact: pamela wright ; 12625 wetmore; ste. 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4707263
• MDR Text Key: 5722506
• Report Number: 3007420694-2015-00075
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 03/20/2015

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: Health Professional
• Device Model Number: AR*
• 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: 04/09/2015
• Distributor Facility Aware Date: 03/20/2015
• Event Location: Other
• Date Report to Manufacturer: 04/09/2015
• Initial Date Manufacturer Received: 03/20/2015
• Initial Date FDA Received: 04/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2001
• 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