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

Model Number PINNACLE

Device Problem Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/03/2018

Event Type  No Answer Provided  

Event Description

I have noticed that the movable rail on my stair lift is cracking at the hinge.

• Brand Name: HARMAR PINNACLE BATTERY POWERED STAIR LIFT
• Type of Device: POWERED CHAIR STAIRWAY LIFT
• Manufacturer (Section D): HARMAR MOBILITY LLC
• MDR Report Key: 7999982
• MDR Text Key: 125104249
• Report Number: MW5080795
• Device Sequence Number: 1
• Product Code: PCD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: PINNACLE
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1