MAUDE Adverse Event Report: ARJOHUNTLEIGH MAGOG INC. SARA STEDY; CHAIR, WITH CASTERS

Device Problems Use of Device Problem (1670); Device Tipped Over (2589)

Patient Problems Bruise/Contusion (1754); Injury (2348)

Event Date 07/25/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information will be provided upon conclusion of the manufacturer's investigation.

Event Description

Arjohuntleigh received customer complaint for sara stedy active lift.It was reported that during transfer from bed to the sara stedy, the patient care technician was loading patient onto device.The patient's caregiver stepped in and reached over safety bar to help the resident while standing.At this moment sara stedy came off the ground in the front and landed on the patient care technician's foot.As a result, their foot was injured.

Manufacturer Narrative

(b)(4).An investigation was carried out into this complaint.Arjohuntleigh received customer complaint where it was reported that the incident occurred during transfer from seated position at the edge of the bed - to chair.There were two people assisting the transfer.The patient care technician (pct) was loading patient onto sara stedy.At the same time the patient's caregiver stepped in to help while standing in front of the device and reached over safety bar to lift patient up by gait belt.Sara stedy came off the ground in the front and landed on patient care technician's foot.In effect, the patient care technician received a minor injury: bruised toe.After review of reportable complaints for sara stedy and stedy (which has very similar construction), descriptions of two of them suggest relation to events where the person is standing on the device and leaning, causing it to tip or almost tip.Please note that arjohuntleigh manufactured about 9000 stedy and 21000 sara stedy to date.Compared to the amount of sold devices and in comparison to their daily use, amount of reportable complaints with this failure mode is considered to be very low.From the gathered information, and also confirmed by the customer, it can be read that sara stedy tipped most likely because it was not operated according to the instruction for use (ifu), which was delivered with the device.The stability of the device depends on a variety of factors.However, there are mainly four factors that may be considered, which are the utilization of the device, the environment of use, the stability inherent to the design of the device and the stability inherent to the condition of the device at the time of use.The three last ones are not considered to have contributed to the outcome of the event, since the device was not being maneuvered when the event occurred and the sara stedy meets the static stability requirements of iso 10535:2006.There was no indication of technical device malfunction.However, the position of the caregiver is considered to have contributed to the instability, as the caregiver was leaning forward over the crossbar while helping the patient to stand up.This way of handling is not consistent with the ifu, which clearly states how this type of transfer should be carried out.Since there is no need for a caregiver to step into the sara stedy and lean forward in order to perform a patient transfer, since no problems were found with the floor lift, it is considered the lift was not being used as per its instructions for use.If sara stedy's handling procedures were followed in accordance to instruction for use, there would be no patient or caregiver at risk.We find this complaint to be reportable to the competent authorities in abundance of caution, due to the risk of tipping for the caregiver and risk of body trapping for the patient care technician.There was no indication of product malfunction.It was being used for patient handling and likely due to use error contributed to the outcome of the event.

Event Description

Arjohuntleigh received customer complaint where it was reported that the incident occurred during transfer from seated position at the edge of the bed - to chair.There were two people assisting the transfer.The patient care technician (pct) was loading patient onto sara stedy.At the same time the patient's caregiver stepped in to help while standing in front of the device and reached over safety bar to lift patient up by gait belt.Sara stedy came off the ground in the front and landed on patient care technician's foot.Initially it was reported that the foot of the patient care technician was injured.On (b)(6) 2016 arjohuntleigh received information that the injury was bruised toe.

• Brand Name: SARA STEDY
• Type of Device: CHAIR, WITH CASTERS
• Manufacturer (Section D): ARJOHUNTLEIGH MAGOG INC.; 2001, tanguay; magog, qc J1X 5 Y5; CA J1X 5Y5
• Manufacturer (Section G): ARJOHUNTLEIGH MAGOG INC.; 2001, tanguay; magog, qc J1X 5 Y5; CA J1X 5Y5
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 5972549
• MDR Text Key: 55436041
• Report Number: 9681684-2016-00040
• Device Sequence Number: 1
• Product Code: INM
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 11/24/2016,08/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/24/2016
• Distributor Facility Aware Date: 08/26/2016
• Event Location: Hospital
• Date Report to Manufacturer: 11/24/2016
• Date Manufacturer Received: 10/27/2016
• 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