MAUDE Adverse Event Report: HARMAR MOBILITY LLC PINNACLE STAIRLIFT; POWERED STAIRWAY CHAIR LIFT

Model Number	SL300
Medical Device Problem Code	Installation-Related Problem (2965)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Date of Event	10/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The pinnacle sl300 was not returned for evaluation.The information currently available to harmar is that the unit was originally installed by one dealer on (b)(6) 2025 and was in use for 6 months by the original owner.It was then uninstalled sometime on (b)(6) 2025 and re-installed by a second dealer at a different residence where the impacted end user resided.Based on currently available information, it is unclear what may have caused the device to suddenly descend during operation as reported.Should additional information become available, a supplemental report will be submitted as necessary in accordance with 21 cfr 803.56.This report does not constitute an admission or conclusion by the manufacturer or fda that the manufacturer or its device caused or contributed to the event described in this report.
Event or Problem Description
It was reported that when the end user was riding the pinnacle sl300 up the stairs, the chair descended abruptly near the top of the staircase, thrusting the user onto the floor.It was also reported that the end user experienced humeral, rib, and ankle fractures and a degloved lower right leg requiring hospitalization and had surgery to reduce the ankle fracture.The reporter stated that the sl300 was installed at the end user's residence on (b)(6) 2025, and the event happened approximately 30 minutes after the installation.

• Brand Name: PINNACLE STAIRLIFT
• Common Device Name: POWERED STAIRWAY CHAIR LIFT
• Manufacturer (Section D): HARMAR MOBILITY LLC; 1204 s. dean ave; raymore MO 64083
• Manufacturer Contact: donald rea ; 1204 s. dean avenue; raymore, MO 64083 ; 8167442415
• MDR Report Key: 24537763
• Report Number: 3004153586-2026-00002
• Device Sequence Number: 13004700
• Product Code: PCD
• UDI-Device Identifier: 00817650026188
• UDI-Public: 00817650026188
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/06/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: SL300
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/22/2025
• 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: Hospitalization; Disability
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White