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

Model Number	NTB2000
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Fall (1848)
Date of Event	01/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Please note that sara stedy mobile active lift is delivered with the instructions for use, 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.Based on the information collected to date, the exact root cause for this event was not possible to be established.Looking at the incident scenario it has been established that a floor lift was used for patient handling at the time of the event.The brakes defect was found, and from that perspective the device did not meet its specification.The complaint was decided to be reportable due to the allegation that the patient fell during transfer.
Event or Problem Description
It was repotted that during transfer patient fell out from the device.There was no injury reported.The customer stated that the castor brakes were not working.After the event the arjo representative tested the device.The device evaluation revealed that the castor brakes are hard to lock and more force is needed to lock the brakes.The brakes were replaced.The brakes malfunction by itself did not cause the patient fall.During interview the customer denied to provide any additional information regarding event circumstances.It was not possible to determine the course of events leading to patient fall.

• Brand Name: SARA STEDY
• Common Device Name: 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: 16275945
• Report Number: 9681684-2023-00006
• Device Sequence Number: 6645924
• Product Code: FSA
• UDI-Device Identifier: 05055982773683
• UDI-Public: (01)05055982773683(11)200714
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: NTB2000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2023
• Initial Report FDA Received Date: 02/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female