MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP Z O.O SYSTEM 2000; HYDRO-MASSAGE BATH, INSTITUTIONAL

Model Number AAR31202-CA

Device Problem Device Tipped Over (2589)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Please note that previous medwatch reports for this product may have been submitted for the manufacturing site (b)(4).As of 2014 that number was de-activated due to the site no longer shipping product to the usa.From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh (b)(4) complaint handling establishment and any medwatch reports will be submitted under (b)(4).Additional information will be provided upon the investigation completion.

Event Description

Arjohuntleigh has received a customer complaint where it was indicated that the tub had tipped over, not right over but up against the wall.The resident was not in the tub at the time, but in the sling.The caregiver and resident were not injured.This issue was not reported to the staff or nursing manager and the maintenance person was unfamiliar with the care aid so the facility has no report or indication that this event occurred.The preventive maintenance was successfully performed with no outstanding issues and could not find any witness marks that would indicate a problem with the tub.The tub functioned normally, the legs were torqued as per specification, tub shell was torqued.The feet of the tub were straight and appeared in good working order.The tub cannot be tipped by pushing on it or by jamming an object below it.

Manufacturer Narrative

(b)(4).Please note that previous medwatch reports for this product may have been submitted for the manufacturing site arjo hospital equipment (b)(4) (under registration #(b)(4)).As of 2014 that number was de-activated due to the site no longer shipping product to the usa.From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh (b)(4) complaint handling establishment and any medwatch reports will be submitted under registration #(b)(4).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 due to misuse.Arjohuntleigh manufactured over (b)(4) system (b)(4) baths to date.With the amount of sold devices and to the comparison of a daily use, we find the occurrence rate for this kind of events in last 5 years to be very low and stable.Product instruction for use (ifu) is provided with each device.Ifu (operating and daily maintenance instructions 04.Ar 08/2 gb from march 2000) warns: "when lowering the bath tub the operator must ensure that there are no obstructions in the immediate vicinity that could impede its downward movement.Failure to remove obstructions could result in severe injury to operator/resident and damage the tub.When raising the bath, ensure that no part of the resident lift chair or stretcher is in contact with the bottom or rim of the tub.Do not allow the resident or operator to sit on the end or side of the bath tub." additionally, the equilibrium calculation has been established on system 2000 tubs and included in test report (b)(4) dated on 2007-apr-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 182 kg 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 show 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 rise by itself during normal use of the product.From above evaluation and similar complaints received to date, it is very likely that the tub was lowered onto lift's actuator and was either lowered further by the caregiver or the lift was raised causing tipping of the bath and its dislocation.Despite the technician's efforts, it was impossible to reach the witness of the incident, therefore there is no information about the exact incident description.It is known that the lift used at the moment of incident was alenti and during the visit at the customer the technician witnessed its bent arm - however there is no confirmation that this damage was caused by investigated incident.From above findings we conclude that this incident was most likely related to use error - not following warnings included in the instruction for use.The received information and our evaluation as described above are showing that if system 2000's warnings were followed in accordance to product labeling, there would be no patient or caregiver at risk.The device was inspected by an arjohuntleigh representative at the customer site and found to be up to the specification - no fault was found that could cause or contribute to the reported incident.The device was being used for patient handling and in that way contributed to the incident.

• Brand Name: SYSTEM 2000
• Type of Device: HYDRO-MASSAGE BATH, INSTITUTIONAL
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP Z O.O; ks. wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP Z O.O; ks. wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer Contact: kinga stolinska ; ks. wawrzyniaka 2; komorniki,, TX 62-05-2 ; PL 62-052 ; 2103170412
• MDR Report Key: 6173066
• MDR Text Key: 62540372
• Report Number: 3007420694-2016-00253
• 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
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 01/13/2017,11/23/2016

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: Other Caregivers
• Device Model Number: AAR31202-CA
• 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: 01/13/2017
• Distributor Facility Aware Date: 11/23/2016
• Device Age: 128 MO
• Event Location: Nursing Home
• Date Report to Manufacturer: 01/13/2017
• Initial Date Manufacturer Received: 11/23/2016
• Initial Date FDA Received: 12/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2006
• 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