MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. SARA STEDY; CHAIR, WITH CASTERS

Model Number	NTB2000
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.Results will be updated in the final report.
Event or Problem Description
A near miss has been reported.As reported ¿a resident slipping knee/leg bumped on knee support causing bruising due to carpet worn.¿.
Additional Manufacturer Narrative
It was reported that during a patient transfer onto the sara stedy lift, the patient slipped and made contact with the knee support, resulting in minor injury (bruising to the knee/leg).Initial assessment suggested that a worn carpet may have contributed to the incident.However, following an inspection conducted by a service personnel, the carpet was found to be in acceptable condition.The carpet on the lift serves as the surface on which the patient stands during transfer procedures.It is a material covering the base of the lift.Wear was observed on one of the rear castors, but based on product knowledge, this component is not considered a contributing factor to this type of incident.The customer did not provide any further details regarding the circumstances of the event.The sara stedy instructions for use (001.20815) include step-by-step guidance for performing safe transfers.If needed the sling (back support strap) can be used.The ifu also states: ¿visually check exposed surfaces for damage, sharp edges, etc." if any such issues are observed, the lift should not be used.Due to the limited information provided in the complaint, it is not possible to determine the cause of the patient slipping from the lift.The arjo device was used for a patient treatment when the event occurred and from that perspective it played a role in the event.No malfunction that could have led to the incident was found during the device evaluation.The complaint was decided to be reportable due to the patient slipping out of sara stedy floor lift.
Additional Manufacturer Narrative
The carpet and lift was visually inspected and found the carpet in good condition.One rear caster of the lift showed wear.Casters have been replaced.The gathered data is pending analysis.Once completed a final report will be provided.The device is distributed outside the us and no gudid information exists.Udi#(b)(4).

• Brand Name: SARA STEDY
• Common Device Name: CHAIR, WITH CASTERS
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• Manufacturer Contact: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 22848263
• Report Number: 9681684-2025-00080
• Device Sequence Number: 8403675
• Product Code: INM
• UDI-Device Identifier: 05055982773683
• UDI-Public: (01)05055982773683(11)220512
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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,Followup,Followup
• Report Date (Section B): 10/01/2025

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 09/16/2025; 10/01/2025
• Date Device Manufactured: 09/16/2025
• 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