MAUDE Adverse Event Report: SAVARIA NEDERLAND B.V. SAVARIA NEDERLAND BV; STAIRLIFT

Model Number	1100
Medical Device Problem Codes	Mechanical Problem (1384); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The chair lost its hold and slid down when the end-user stopped temporarily mid way going down the stair.
Additional Manufacturer Narrative
End user reported sliding.Maybe related to mechanical issue because component contributed safety changed apr 2024 ecn2572.

• Brand Name: SAVARIA NEDERLAND BV
• Common Device Name: STAIRLIFT
• Manufacturer (Section D): SAVARIA NEDERLAND B.V.; savaria nederland b.v.; newtonstraat 35; heerhugowaard, 1704S B; NL 1704SB
• Manufacturer (Section G): SAVARIA NEDERLAND B.V.; savaria nederland b.v.; newtonstraat 35; heerhugowaard, 1704S B; NL 1704SB
• Manufacturer Contact: peter laan ; savaria nederland b.v.; newtonstraat 35; heerhugowaard, 1704S-B ; NL 1704SB
• MDR Report Key: 24912393
• Report Number: 3013423626-2026-00001
• Device Sequence Number: 9067540
• Product Code: PCD
• UDI-Device Identifier: 08719326254326
• UDI-Public: 8719326254326
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 04/16/2026

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: Lay User/Patient
• Device Model Number: 1100
• Device Catalogue Number: 1100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/12/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown