MAUDE Adverse Event Report: ARJOHUNTLEIGH MAGOG INC. SARA STEDY; LIFT, PATIENT, NON-AC-POWERED

Model Number NTB2000

Device Problem Device Slipped (1584)

Patient Problems Fall (1848); Pain (1994)

Event Date 03/07/2023

Event Type  malfunction  

Manufacturer Narrative

After the event the arjo representative conduct the device evaluation.The functional and visual inspection did not reveal any malfunction.The customer allegation was not confirmed.Please note that sara steady mobile active lift is delivered with the instructions for use, which provides information for correct and safe use of the device e.G.: transferring the patient at the toilet: bring the patient over to the toilet and apply the brakes.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 steady unit was found, so the product was up to the manufacturers specification after the event.The event occurred during the residents transfer 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.

Event Description

It was reported that a resident was transferred to a toilet.When a caregiver was trying to assist the resident the lift castor skidded.As a consequence the resident dropped on the toilet seat and reported pain.No other injury was reported.The customer suggested that the castor brake did not lock properly.After the event the arjo representative conducted the device evaluation.The functional and visual inspection did not reveal any malfunction.The customer allegation was not confirmed.

• Brand Name: SARA STEDY
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay street; magog, quebec J1X 5 Y5; CA J1X 5Y5
• Manufacturer (Section G): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay street; magog, quebec J1X 5 Y5; CA J1X 5Y5
• Manufacturer Contact: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 16671662
• MDR Text Key: 312691429
• Report Number: 9681684-2023-00022
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: NTB2000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2016
• 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): Other
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Weight: 85 KG