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

Model Number AD31801US1011

Device Problem Filling Problem (1233)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was initially reported to arjohuntleigh representative that: "a disoriented resident went into the tub room and climbed in the tub and pressed the fill button.Staff could not get in as door was locked from the inside.The manager was walking by, heard water running and found a way to unlock the door.The water was about 2 inches below the edge of the tubshell at this time, since the autofill did not shut off the filling of the tub.The water was drained and the resident was fine.".

Manufacturer Narrative

An investigation was carried out into this complaint.When reviewing similar reportable events for system 2000 we have found only one complaint related to issue where the patient snap in the bathroom and start therapy without caregiver permission.The device was being used for the patient therapy- disoriented resident snap in the bathroom, pressed the fill button and went into the bath.Staff could not get in, as door was locked from the inside and in that way it contributed to the event.That patient has been left without caregiver when the event occurred.The bath has been out of the specification in the time when the event occurred due to fact that autofill function did not work correctly.All devices are equipped with instruction for use which clearly inform how to correct use the device.Ifu for system 2000 contains information: "this equipment is intended for therapeutic bathing and showering hospital or care facility resident sunder the supervision of trained skilled nursing staff in accordance with the instructions outlined in the instructions for use (ifu).All other uses must be avoided." warning: - "to avoid injury, make sure that the patient is not left unattended at any time." moreover the ifu contains preventive maintenance section which clearly inform that: -once a week caregiver should "perform functionality test" it can be established that bath was being used for patient handling but it appears it contributed to the event likely due to a use error.Patient has been left unattended during therapy.Please note that if caregiver would have followed every guideline given in instruction for use (patient is not left unattended) there would be no user at risk.Due to the nature of this incident we are reporting this event to competent authorities in the abundance of caution - even though no injury occurred, there was a probability of harm with a high severity.

• 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: 5747817
• MDR Text Key: 48105111
• Report Number: 3007420694-2016-00116
• 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: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 06/24/2016,06/14/2016

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: No Information
• Device Model Number: AD31801US1011
• 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: 06/24/2016
• Distributor Facility Aware Date: 06/14/2016
• Device Age: 11 MO
• Event Location: Nursing Home
• Date Report to Manufacturer: 06/24/2016
• Initial Date Manufacturer Received: 06/14/2016
• Initial Date FDA Received: 06/24/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2016
• 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