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

Model Number NTB2000

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 03/12/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Arjohuntleigh was informed about an incident which occurred during the use of sara stedy active lift.It was indicated that during transfer from chair to sara stedy, patient stood up and then fell.The caregiver used sara plus to lift the resident and noticed the leg fracture.As a result, the patient required surgery of broken femur.

Manufacturer Narrative

An investigation was carried out into this complaint.Arjohuntleigh was informed about an event which occurred in (b)(6) hospital in (b)(6).Following the information reported, a patient who was going to be transferred to the restroom with staff assistance has experienced an unforeseen orthostatic hypotensive event upon standing.This condition led to patient's fall.When the caregiver attempted to lift the resident, a leg fracture was noticed.The patient had a broken femur which required further medical intervention - a surgery was performed.The lift was withdrawn from use and evaluated by arjohuntleigh representative after the event.The device was found in the excellent condition, fully functional.When reviewing similar reportable events with the involvement of the sara stedy it was possible to determine a number of events presenting a similar scenario covering patient's fall.The occurrence rate observed for this failure mode is currently considered to be very low.The sara stedy is a mobile active lift intended to be operated on horizontal surfaces for transferring patients and residents in hospitals, nursing homes or other health care facilities.It is suitable for transferring patient to/from a chair, a wheelchair, a bed and a toilet.Basing on the information gathered, it appears most likely that the patient has fallen down unexpectedly, during the attempt to stand up.Patient has experienced an unforeseen weakness which led to a lower ability of self-support.This impacted the required level of mobility to continue the transfer procedure.As the sequence of events was dynamic (the patient has lost his balance shortly after standing up), the fall was not avoided by the caregiving staff despite alleged proper patient's clinical assessment.The instructions for use (ifu 001-12325 en, feb 2014) clearly defines procedure of safe lift operation.Several recommendations and warnings were issued by arjohuntleigh in order to assure the safety of usage: "this mobile patient lift must be used by a caregiver trained with these instructions and qualified to work with the patient to be transferred and should never be used by patients on their own." "before attempting a transfer, a clinical assessment of the patient's suitability for transfer should be carried out by a qualified health professional considering that, among other things, the transfer may induce substantial pressure on the patient's body." device instructions leave it for the caregiving staff to evaluate patient's condition and their suitability for the transfer.The number of staff to assist the transfer and patient's medical evaluation plays a significant role in the process - it allows to securely conduct the procedure, involving all necessary features.Nevertheless, it appears possible that some unforeseen changes of health condition may occur at every stage of the transferring process and significantly impact it, depending on the nature of the event.As a medical history of the resident or detailed information regarding his health state prior or after the event was not provided, it is not possible to exclude the potential scenario of some use error aspects (elements of an incorrect assessment) contributing to the outcome of the event.Following technical evaluation of the device, when the resident fell down, arjohuntleigh system met its performance specifications and performed as intended.Basing on the information gathered, it is considered most likely that the unfortunate sequence of events determined by patient's condition have led to the accidental fall of a patient experiencing unforeseen orthostatic hypotensive condition, which resulted in serious health consequence.Due to the nature of this incident we are reporting this event to competent authorities taking into consideration a serious outcome of the incident.It has been established that sara stedy was in use for a patient treatment at the time of the event but our review did not identify any direct indication of its contribution to the outcome of the event.Based on the above, the device was found not to have malfunctioned (was performing up to the specification) when the event took place.

• Brand Name: SARA STEDY
• Type of Device: CHAIR, WITH CASTERS
• Manufacturer (Section D): ARJOHUNTLEIGH MAGOG INC.; 2001, tanguay; magog, J1X 5 Y5; CA J1X 5Y5
• Manufacturer (Section G): ARJOHUNTLEIGH MAGOG INC.; 2001, tanguay; magog, J1X 5 Y5; CA J1X 5Y5
• Manufacturer Contact: kinga stolinska ; ul. ks. piotra wawrzyniaka 2; komorniki, 62-05-2 ; PL 62-052 ; 98282467
• MDR Report Key: 6479554
• MDR Text Key: 72330788
• Report Number: 9681684-2017-00026
• 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
• Type of Report: Initial,Followup
• Report Date: 05/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Model Number: NTB2000
• 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: 05/26/2017
• Distributor Facility Aware Date: 03/14/2017
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/26/2017
• Date Manufacturer Received: 04/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2016
• 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): Hospitalization; Required Intervention