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

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information will be provided following the conclusion of the investigation.

Event Description

It was initially reported that bath was tipping during use.Arjohuntleigh representative was informed by caregiver that patient seat on the end of the bath and was active moving on this point.Patient was left without caregiver during therapy.

Manufacturer Narrative

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.The device was being used for the patient therapy- during bathing patient seat on the end of the tub and started to active moving.Bath almost tip over, and in that way contributed to the event.It was reported by the caregiver from the facility that patient has been left without caregiver when the event occurred.Moreover further examination by arjohuntleigh's representative revealed no faults within a device - function test showed that the device was working to its specification.No repair or adjustment has been done.The technician has managed to recreate the event: bath has been filled automatically and placed on the highest position.The technician applied their full weight on the tub (the technician's weight is (b)(6)), nothing happened.When the technician hung on and moved up and down violently, the device moved, it was possible to be made to recline.All devices are equipped with instruction for use, which clearly inform how to correct use and maintenance the bath.Instruction for use for system 2000 contains warnings which clearly inform that: "to avoid falling, make sure the resident always remains in a seated position." "to avoid injury, ensure that the resident is not left unattended at any time." after reviewing the complaint it comes forward that the device was according to specification when the event occurred.The device was in good working condition, no failure was detected.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.Patient has been left unattended during therapy.Personnel from facility confirm that patient seat on the edge/end of the bath and was actively moving on that point.Please note, that if caregiver would have followed every guideline given in instruction for use (patient is not left unattended, and patient remains in a seated position) 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: 5633356
• MDR Text Key: 44450891
• Report Number: 3007420694-2016-00084
• Device Sequence Number: 1
• Product Code: ILM
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 06/03/2016,04/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• 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: 06/03/2016
• Distributor Facility Aware Date: 04/07/2016
• Device Age: 18 MO
• Event Location: Nursing Home
• Date Report to Manufacturer: 05/05/2016
• Date Manufacturer Received: 04/07/2016
• Date Device Manufactured: 01/09/2014
• 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