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

Model Number NTB2000

Device Problem Insufficient Information (3190)

Patient Problems Abrasion (1689); Bruise/Contusion (1754); Fall (1848)

Event Date 04/30/2021

Event Type  Injury  

Manufacturer Narrative

The device has been rejected by the customer and returned to arjo.Based on the collected information no defect within the device was found.The investigation is on-going and additional information will be provided in the next report.

Event Description

Arjo was notified about an event with involvement of the sara stedy active lift, which was reported by the family member of the involved person.The patient (approximately 6'2" in height) was attempting to use the lift, when he slipped/fell backwards off the device.The patient sustained a few bruises and scrapped his shins.According to the provided information, the person involved was not hospitalized.

Manufacturer Narrative

Arjo was notified about an event with involvement of the sara stedy active lift, which was reported by the family member of the involved person.The patient (approximately 6'2" in height) was attempting to use the lift, when he slipped/fell backwards off the device.The patient sustained a few bruises and scrapped his shins.According to the provided information, the person involved was not hospitalized.The device has been rejected by the customer and returned to arjo.Based on the collected information no defect within the device was found.It was not possible to determine the course of events leading to patient fall.It was not confirmed that the device by itself in any way contributed to the incident occurrence.Please note that sara stedy mobile active lift is delivered with the instructions for use (ifu; 001-12325-en rev.6), which provides information for correct and safe use of the device e.G: ¿to avoid falling, make sure that the patient is positioned correctly during transfer¿ sara stedy must be used by a caregiver trained with ifu and qualified to work with the patient to be transferred and should never be used by patients on their own.This device was designed and tested according to standard of iso10535:2006.Based on the information collected to date, the exact root cause for this event was not possible to be established.In summary, no malfunction within the sara stedy unit was found, so the product was up to the manufacturer¿s specification after the event.The event occurred during attempt to use the device with the patient and in that way the device was involved with the reported incident.The complaint was decided to be reportable based on the allegation that patient fell out of the device.

• Brand Name: SARA STEDY
• Type of Device: CHAIR, WITH CASTERS
• Manufacturer (Section D): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay street; magog, quebec J1X 5 Y5; CA J1X 5Y5
• MDR Report Key: 11869684
• MDR Text Key: 264088815
• Report Number: 9681684-2021-00027
• Device Sequence Number: 1
• Product Code: INM
• UDI-Device Identifier: 05055982773683
• UDI-Public: (01)05055982773683(11)210315
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: NTB2000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other