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

Model Number SL600HD

Device Problem Component Misassembled (4004)

Patient Problem Pain (1994)

Event Date 05/05/2018

Event Type  malfunction  

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 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
• Type of Device: POWERED STAIRWAY CHAIR LIFT
• Manufacturer (Section D): HARMAR MOBILITY, LLC; 18505 e 163rd street; lake winnebago MO 64034
• Manufacturer (Section G): HARMAR MOBILITY; 18505 e 163rd street; lake winnebago MO 64034
• Manufacturer Contact: dawn watters ; 2075 47th street; sarasota, FL 34234 ; 9413087398
• MDR Report Key: 7705796
• MDR Text Key: 114806252
• Report Number: 3004153586-2018-00001
• Device Sequence Number: 1
• Product Code: PCD
• UDI-Device Identifier: 00817650022395
• UDI-Public: 00817650022395
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 05/08/2018
• Initial Date FDA Received: 07/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Weight: 163