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

Model Number AP32201GB1000

Device Problems Device Tipped Over (2589); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2015

Event Type  malfunction  

Manufacturer Narrative

(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 33000 system 2000 baths to date.With the amount of sold devices and to the comparison of a daily use, we find the occurrence rate for these kinds of events in last 5 years to be very low and stable.The device was inspected by an arjohuntleigh representative at the customer site and found to be to the specification - no fault was found that could cause or contribute to the reported event.The device was being used for patient handling and in that way contributed to the event.Product instruction for use (ifu) is provided with each device.Ifu (operating and product care instructions 04.Ar 08/ 8gb from december 2006) 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 establish on system 2000 tubs.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 above evaluation and similar complaints received to date, it is very likely that tub was lowered onto lift's actuator and was either lowered further by the caregiver or lift was raised causing tipping of a bath and its dislocation.The bath's movement away from its original position caused the waste pipe to become detached for the trap and leaking water.Despite our efforts the customer did not provide information about the exact event description where tub was tipping during use.No detailed information about supporting equipment was provided either.Device examination performed by a service technician showed that there was no failure that could contribute to this incident, bath was fully operational - device was working in accordance to its specification.The only failure that was found was disconnected drain (waste) pipe.From above findings we conclude that this incident is related to user error - not following warnings included in 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.

Event Description

It was initially reported by company representative that "prior to bath being used, it would appear that the bath had been disturbed/moved which caused the waste pipe to become detached for the trap.After use, water was drained from bath, which leaked on to the floor causing a small flood." additionally information revealed indication of an adverse event: [(b)(6) 2015] "it would appear that the bath tipped and moved during use.The tub was full with water with a patient in at the time.".

• 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: 5144107
• MDR Text Key: 28043516
• Report Number: 3007420694-2015-00194
• Device Sequence Number: 1
• Product Code: ILJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Repair
• Report Date: 10/12/2015,09/16/2015

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: Other Caregivers
• Device Model Number: AP32201GB1000
• 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: 10/12/2015
• Distributor Facility Aware Date: 09/16/2015
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/12/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2009
• 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