MAUDE Adverse Event Report: HARMAR MOBILITY, LLC PINNACLE HEAVY DUTY; POWERED STAIRWAY CHAIR LIFT

Model Number	SL600HD
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This type of product performance issue has not been reported previously.During the on-site incident investigation, several screws that connect the chassis motor to the frame were found to be loose or missing.The unit was sent to harmar for further investigation in may where it was determined that the screws were loose or missing due to the lack of loctite threadlocker application on the screws.
Event or Problem Description
On (b)(6) 2018 the user got on the stair lift chair at the bottom step and was riding upwards to the top landing when the stair lift made a popping sound and the stair lift seat/chassis descended back down the staircase to the end of the rail.The user stepped off the stair lift as it descended and sustained minor pain in her leg and a small cut on her finger.

• Brand Name: PINNACLE HEAVY DUTY
• Common Device Name: POWERED STAIRWAY CHAIR LIFT
• Manufacturer (Section D): HARMAR MOBILITY, LLC; 18505 e 163rd street; lake winnebago MO 64034
• MDR Report Key: 7705796
• Report Number: 3004153586-2018-00001
• Device Sequence Number: 19109269
• Product Code: PCD
• UDI-Device Identifier: 00817650022395
• UDI-Public: 00817650022395
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection,Replace
• Type of Report: Initial
• Report Date (Section B): 07/17/2018

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: SL600HD
• Device Catalogue Number: SL600HD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2018
• Initial Report FDA Received Date: 07/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 163