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

Model Number	1100
Medical Device Problem Code	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
Additional Manufacturer Narrative
Upon initial receipt of report, we did not believe it was a reportable event.Upon further investigation, the event deemed reportable and escalated on 04/08/2026.
Event or Problem Description
The chair lost its hold and slid down when the end-user stopped temporarily mid way going down the stair.

• Brand Name: SAVARIA NEDERLAND BV
• Common Device Name: STAIRLIFT
• Manufacturer (Section D): SAVARIA NEDERLAND B.V.; newtonstraat 35; heerhugowaard, 1704S B; NL 1704SB
• MDR Report Key: 24912396
• Report Number: 3005753836-2026-00001
• Device Sequence Number: 9067542
• Product Code: PCD
• UDI-Device Identifier: 08719326254326
• UDI-Public: 8719326254326
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/15/2026
• Report Date (Section F): 04/15/2026

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/26/2026
• Device Age: 3 YR
• Event Location: Home
• Date Report to Manufacturer: 04/15/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/17/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown