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

Model Number AP31801US1010

Device Problem Device Tipped Over (2589)

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

The arjohuntleigh has been informed that the bath tilted towards the doorway when it got caught on a container that was by the head of the tub.

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.The caregiver did not notice that sharp container was situated under the bath.While caregiver was lowering the bath onto obstruction bath tilted forwards and in that way contributed to the event.The bath was according to the specification in time when the event occurred.The device was in good working condition.The customer was managed to recreate the event.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 entrapment of the patients or caregivers legs or feet, make sure that they are kept clear of all obstacles." "to avoid the device in use from tipping, do not raise or lower other equipment close to it and be aware of stationary object when lowering." according to the above the device was found to have been to specification when the event took a place.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 the device was according to specification when the event occurred.The device was in good working condition.The bath tilted forward due to contact with obstruction.Please note, that if caregiver would have followed every guideline given in instruction for use 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: 5760988
• MDR Text Key: 48510963
• Report Number: 3007420694-2016-00117
• 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: 07/28/2016,06/06/2016

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: AP31801US1010
• 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: 07/28/2016
• Distributor Facility Aware Date: 06/06/2016
• Device Age: 18 MO
• Event Location: Nursing Home
• Date Report to Manufacturer: 06/30/2016
• Initial Date Manufacturer Received: 06/06/2016
• Initial Date FDA Received: 06/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2014
• 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