MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB SYSTEM 2000; BATH, HYDRO-MASSAGE

Model Number AR33311-US

Device Problem Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information will be provided upon conclusion of the manufacturer's investigation.

Event Description

(b)(4) was informed about an incident which occurred during the use of system 2000 tub.It was indicated that the tub raised up by itself during transfer of the resident on the miranti lift.The miranti was above the tub edge, what caused the tub to raise the miranti from the floor.Fortunately, the caregiver was able to pull the miranti off the edge of the tub.No injury was reported.The tub was moving all the way up until it reached the top of its travel.The emergency lowering lever did not work at the time of the incident, the tub movement was stopped when the power cord was pulled from the wall.Once it was plugged back in, the tub operated normally.

Manufacturer Narrative

An investigation was carried out into this complaint.Investigation received information about incident that occurred in a(b)(6) center.It was reported that during transfer of the resident on miranti hygienic lift over the edge of system 2000 tub, the tub raised up by itself.In effect, miranti was also raised, but the caregiver was able to pull the lift from the tub edge.The caregiver tried to cease the bath movement by operating buttons on the panel or emergency lowering feature, but it was impossible.The tub traveled all the way up and the motor sounded like it was still trying to move up.After pulling the power cord from the wall and plugging it back, the tub operated normally.The resident was safely taken out from the tub, no injury was reported.When reviewing similar reportable events, we have found one other case that may relate to the issue investigated here: tub operates un-commanded during use.Taking into consideration number of manufactured system 2000 tubs, the occurrence rate of reportable complaints with this failure mode is very low.After inspecting the device, the technician tested the tub and the uncontrolled movement did not happen again, no failure has been found within device.In this case the panel and overlay buttons were checked and found to be in good condition, therefore, no part replacement was performed.In this particular case we also cannot assume that the un-commanded movement of the device has been caused by accidental button activation on the control panel.The technician tried to reach the buttons with miranti lift by maneuvering in different positions, but he found no such possibility.Arjohuntleigh representative who examined the device suggested that power surges may be a contributing factor to the issue occurrence.Please note that system 2000 bath is in conformity with all the emc requirements according to en60601-1-2:2007 and iec60601-1-2:2007.Involved product has been produced in december 2006, while the expected lifetime of this equipment is 10 years.Therefore the age of device and its normal wear could be considered as additional contributing factors here.To sum up, based on the information collected to date and provided additional information, we were not able to find a direct cause of un-commanded movement occurrence.We can only assume that power surges or other interference with the tub electronics, together with the age of device, may be a contributing factors, but no technical deficiency with the device was found.Although in the investigated complaint there was no adverse outcome, based on a potential for device tipping and harm with high severity we determined to view this complaint as reportable in the abundance of caution.The device was used for patient hygiene, and by this it played a role in the event.

• Brand Name: SYSTEM 2000
• Type of Device: BATH, HYDRO-MASSAGE
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov, 24121 ; SW 24121
• Manufacturer (Section G): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov, 24121 ; SW 24121
• Manufacturer Contact: kinga stolinska ; ul. ks. piotra wawrzyniaka 2; komorniki, 62-05-2 ; PL 62-052 ; 98282467
• MDR Report Key: 6489248
• MDR Text Key: 72655259
• Report Number: 3007420694-2017-00079
• Device Sequence Number: 1
• Product Code: ILJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/12/2017

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: AR33311-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: 05/12/2017
• Distributor Facility Aware Date: 01/25/2017
• Device Age: 10 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 05/12/2017
• Initial Date Manufacturer Received: 01/25/2017
• Initial Date FDA Received: 04/13/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2006
• 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