FDA Adverse Event Malfunction Summary report: N

PINNACLE SL300

MDR report key: 24381533 · Received February 18, 2026

Report

Report Number: 3004153586-2026-00001
Event Type: Malfunction
Date Received: February 18, 2026
Date of Event: January 19, 2026
Report Date: February 18, 2026
Manufacturer: HARMAR MOBILITY LLC
Product Code: PCD
UDI-DI: 00817650026188
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

THE PINNACLE SL300 CHASSIS WAS RETURNED ON 02/04/2026 AND EVALUATED BY HARMAR ENGINEERING AND QUALITY SUBJECT MATTER EXPERTS. IT WAS DETERMINED THAT THE END CAP SCREWS WERE LIKELY EITHER OVERTIGHTENED AND STRIPPED BY THE INSTALLER, OR THAT THE END CAP WAS OVERTIGHTENED IN PRODUCTION, OR DAMAGED DURING HANDLING AND INSTALLATION. A CAPA HAS BEEN OPENED TO FURTHER INVESTIGATE THE ISSUE AND EVALUATE APPROPRIATE CORRECTIVE AND PREVENTIVE ACTIONS, IF APPLICABLE. 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.

Description of Event or Problem · 0

IT WAS REPORTED THAT WHEN THE END USER WAS RIDING THE PINNACLE SL300 DOWNSTAIRS, THE TRACK'S END CAP FELL OFF AND SEVEAL PIECES OF THE GEAR RACK SLIDE OUT TOWARDS THE BOTTOM OF THE STAIRCASE. THE REPORTER STATED THAT THE END USER CONTINUED TO DESCEND A FEW FEET AND HIT HER WRIST AGAINST THE ARMREST CAUSING THE BRUISING. THE SL300 UNIT WAS INSTALLED IN (B)(6) 2025.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
443201	PINNACLE SL300	Powered stairway chair lift	PCD	HARMAR MOBILITY LLC	SL300		00817650026188

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Female