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

Model Number	NTB2000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided upon investigation conclusion.
Event or Problem Description
The facility stated that a patient arrested whilst in the sara stedy.The facility stated that the sara stedy did not cause or contribute to the patient's arrest and requested arjo for advice on handling a patient who has become unconscious while in the equipment.
Additional Manufacturer Narrative
The device was evaluated by an arjo representative and no malfunction was found.The devices are delivered with instruction for use (ifu 001-12325 rev.8) which provides information on how to correctly use the device.The ifu for sara stedy contains information that: ¿warning: before attempting to a transfer, a clinical assessment of the patient suitability for transfer should be carried out by qualified professional.¿ taking into account all facts, we can state that the event was caused by patient cardiac arrest related to the patient's medical condition.There was no device failure that caused on contributed to it, the device met performance specifications.The device was in use when the issue occurred and from that perspective, it played a role in the event.The complaint was decided to be reportable due to the fact that the patient had a cardiac arrest during the transfer and became unconscious.
Event or Problem Description
Following the information provided, the patient was transferred using the sara stedy active floor lift.During the transfer process, the patient experienced a cardiac arrest and the patient became unconscious while situated within the sara stedy active floor lift equipment.As a consequence of the event the patient slumped forwards over the lift front bar, but with enough weight still on the seat flaps to prevent them being moved.No injury was reported.The device was evaluated by an arjo representative and no malfunction was found.

• 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: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 18354844
• Report Number: 9681684-2023-00085
• Device Sequence Number: 6895734
• Product Code: FSA
• UDI-Device Identifier: 05055982773683
• UDI-Public: (01)05055982773683(11)200910
• Combination Product (Y/N): N
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2024

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
• Device Model Number: NTB2000
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2023
• Supplement Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 01/16/2024
• Date Device Manufactured: 09/10/2020
• 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: Unknown