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

Model Number AP01100-EU

Device Problems Display or Visual Feedback Problem (1184); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problem Burn(s) (1757)

Event Date 11/16/2015

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 the company representative that arjo's bath involved in scalding incident.The device examination showed that the thermometer showed incorrect values due to worn out battery and control knob for water temperature was broken.

Manufacturer Narrative

(b)(4).An investigation was carried out into this complaint.When reviewing similar reportable events for system 2000 baths we haven't found any other similar cases where was scalded due to too hot fill or shower water.There is no complaint trend for these kinds of events.The device was inspected by an arjohuntleigh representative at the customer site and found to be out of its specification.The device was being used for patient handling and in that way contributed to the event.Instruction for use (ifu) is provided with each device.Ifu (operating and product care instructions 04.Ar.09/1 gb from september 1999) provides information about safe and correct use of the product.It informs that user must always make sure that: "the water/shower temperature is checked by hand before the bath" assisted bathing of the patient is described in resident handling instruction (04.Ar.11/1gb from september 1999) which also point out importance of checking water temperature before use: "check the bath water temperature before the resident enters the water" please note that device examination showed that the bolt from the control knob of the mixer was loose and the knob was incorrectly mounted.This failure constitute to an unauthorized modification of a device, as the knob needed to be turned to higher temperature to result in too hot water.The exact cause of this failure is unknown, however there are 3 possibilities for this failure: knob was overturned by the user with the abuse; knob was removed by the customer to change a position of a stop ring, and was incorrectly mounted - too loose; knob was incorrectly maintained as ifu informs that every month the caregiver must "check that all screws, bolts and other joints are perfectly tight".Despite our best efforts we were not able to obtain additional information regarding exact nature of the described malfunction and detailed event description as the facility management has decided not to give any statement regarding this accident.However our evaluation as presented above showed that the most likely cause of the reported scalding incident was related to user error as in accordance to product's operating and product care instructions water temperature should be additionally checked by a naked hand, not only by a displayed value.If the temperature control knob was found to be broken, the complained device should have been taken out of use.If system 2000's bathing procedures were followed in accordance to instruction for use, there would be no patient or caregiver at risk.

• 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: 5294430
• MDR Text Key: 33440459
• Report Number: 3007420694-2015-00230
• Device Sequence Number: 1
• Product Code: ILJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 01/13/2016,11/17/2015

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?: Yes
• Device Operator: Other Caregivers
• Device Model Number: AP01100-EU
• 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: 01/13/2016
• Distributor Facility Aware Date: 11/17/2015
• Device Age: 15 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 12/14/2015
• Initial Date Manufacturer Received: 11/17/2015
• Initial Date FDA Received: 12/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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