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

Model Number 50XR/H

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 10/10/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).An investigation was carried out into this complaint.When reviewing similar reportable events for century we have found very low number of other similar cases where a resident slipped out of the seat.There is no complaint trend for these kinds of events.The received information showed that the involved resident had applied only a single lap belt that can be fastened in front of the chair arm or behind the chair arm.In this case the lap belt was positioned behind the arm on one side, and then ahead of the arm on the other side of the chair.As per the customer: "the fastening buckle was located correctly and the belt was secured correctly".No failure was found that could have caused or contribute to the reported event, please note also that the facility never agreed to an on-site evaluation as there was no malfunction of the device reported.This device is not under arjo's service contract.The received information showed also that when a resident slipped on a seat, the seat belt prevented him from falling from it - device met 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.Operating and daily maintenance instructions ((b)(4) intended for old century baths equipped with lifting unit) includes warnings and safety procedures that are necessary for correct and safe use of the product.Instruction warns inter alia: "make sure the resident is sitting/lying properly with hands and feet placed on the appropriate rest or with hands crossed over the chest.Make sure all straps are in good condition.Make sure the resident is held securely in the transport device with straps properly routed and fastened, so that no part of his/her body can be injured.Move lifts carefully, especially in narrow passages, over threshold or bumps etc." instruction for use recommends also assistance of trained personnel during use of the device: "for safety reasons, we recommend that residents be helped into and out of the bath with the arjo lift hygiene chair or the century saf-lift/saf-kary system, even if the resident is able to walk" with reference to resident's mobility: for residents unable to support themselves: "use both belts and pads supplied with the lift as follows: loop one belt around the chest, underneath the arms, connecting both ends of the belt to the metal knobs located on the top side of the arm/backrest.Loop the second belt around the lap, connecting both ends of the belt to the knobs located near the seat.After both belts are attached, adjust the belts and pads so the resident is secure and comfortable".Ifu provides information about correct applying seat belt and warns: "the seat belt must be securely fastened.Failure to do so could result in injury to the resident".For residents who are unable to support themselves in an upright position: "(.) use the high back seat.It allows you to support the resident with a chest belt.Use the same techniques discussed above for the lap belt to secure the belts on the high back seat in the securest manner for the resident".Figures in ifu show how to place the chest belt across the chest of the resident.From the above evaluation and product ifu's excerpts we find this incident as a unfortunate accident related to resident's condition.There are 3 factors that could have contributed to this: the resident was incorrectly assessed and should use high back seat method for seat belt.The resident was incorrectly positioned in a seat and while lifting out slid down on a seat.The seat belt was not securely fastened and the resident slid through it.We conclude that since no malfunction was found with a device, the use error cannot be ruled out as the exact cause of this incident.It is our opinion that if the century bath's warnings were followed in accordance to instruction for use, there would be no patient or caregiver at risk.

Event Description

Initially it was reported by arjohuntleigh representative that the resident was slipping from a bath's seat: "(.) the resident (who suffers from dementia and osteoporosis) had just finished bathing and the caregivers were attempting to lift out of the tub with the saf-lift kary.The resident slid down on the chair on the way down to the tub, but was held up by the belt.The caregivers lowered the resident completely, then removed the belt and used a passive-type lift and sling to remove from the bath (canvas type of sling; neither of these have been communicated to be arjohuntleigh products).Administrator states that the belt was secured very tightly and that the resident did not seem to have any injuries for 4 to 5 days afterwards.However, the resident's husband believed that there was something wrong with her and requested that she be examined more closely.Facility admitted resident to hospital where x-rays revealed 9 broken ribs".

• Brand Name: CENTURY
• 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: 5232144
• MDR Text Key: 31447536
• Report Number: 3007420694-2015-00214
• 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
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 11/18/2015,10/22/2015

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?: No
• Device Operator: Other Caregivers
• Device Model Number: 50XR/H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/18/2015
• Distributor Facility Aware Date: 10/22/2015
• Event Location: Nursing Home
• Date Report to Manufacturer: 11/18/2015
• Initial Date Manufacturer Received: 10/22/2015
• Initial Date FDA Received: 11/18/2015
• 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): Hospitalization; Required Intervention
• Patient Weight: 71