MAUDE Adverse Event Report: HANDICARE ACCESSIBILITY UK LTD HANIDCARE STAIRLIFTS

Model Number 950PLUS

Device Problems Device Remains Activated (1525); Failure to Auto Stop (2938); Failure to Shut Off (2939); Protective Measures Problem (3015)

Patient Problems Abrasion (1689); Bruise/Contusion (1754); Injury (2348)

Event Date 12/01/2017

Event Type  malfunction  

Manufacturer Narrative

Filing retrospective medical device reports.

Event Description

The seat toggle stuck the user and she was trying to get on the lift and it moved.She fell, cut her arm and brought her down the stairs on her back.User slid off the seat down the side of it and the lift continued to move going down.User wedged down the side and it started to drag her down on her back, user screamed and a lady in the house tried to help, while the lift was about half way down.The lift was stopped by the customer throwing her arm up to knock the stairlift arms up as she's aware that cuts the lift out.This is what we believe think caused the cut on her arm.The lift was moving by itself up to a week before the incident, but in the last couple weeks customer told son that if you push the lift to go down and let go it carried on going, and the son saw this for himself at a later date.An engineer had gone out to change the battery and the tightened the toggle, it didn't spring back 100 % instantly as it should, and it was still a bit slack.The engineer also mentioned that the safety device whereby if you lift the arm up it cuts the lift hadn't been connected it had been connected before this incident.The user was bruised all over but was not hospitalized.

Manufacturer Narrative

Approximately 5429 stairlifts were sold by manufacturer from may 2017 to january 2019.This was the only customer complaint regarding the toggle mechanism.Root cause: initial design testing found that the toggle operated satisfactorily for the first 17,000 cycles, but then the blue toggle moulding would not re-centre itself after activation.A broken or fatigued spring was suspected but on dismantling the arm it became clear that the toggle moulding was binding on the arm casting.The spring was not damaged.A very small amount of grease was applied to the outer diameter of the blue moulding where it rubs on the inner painted bore of the toggle housing.This cured the problem and the toggle continued to 100,000 cycles without further incident.Corrective action: a review of the service and maintenance procedure found that there is no instruction to lubricate the toggle mechanism during regular servicing.Manufacturer will continue to monitor these type of events.

Event Description

The seat toggle stuck the user and she was trying to get on the lift and it moved.She fell, cut her arm and brought her down the stairs on her back.User slid off the seat down the side of it and the lift continued to move going down.User wedged down the side and it started to drag her down on her back, user screamed and a lady in the house tried to help,while the lift was about half way down.The lift was stopped by the customer throwing her arm up to knock the stairlift arms up as she's aware that cuts the lift out,.This is what we believe think caused the cut on her arm.The lift was moving by itself up to a week before the incident, but in the last couple weeks customer told son that if you push the lift to go down and let go it carried on going, and the son saw this for himself at a later date.An engineer had gone out to change the battery and the tightened the toggle, it didn't spring back 100 % instantly as it should, and it was still a bit slack.The engineer also mentioned that the safety device whereby if you lift the arm up it cuts the lift hadn't been connected it had been connected before this incident.The user was bruised all over but was not hospitalized.

• Brand Name: HANIDCARE STAIRLIFTS
• Type of Device: STAIRLIFTS
• Manufacturer (Section D): HANDICARE ACCESSIBILITY UK LTD; 82 first avenue; pensnett estate; kingswinford dudley, DY6 7 FJ; UK DY6 7FJ
• MDR Report Key: 8292942
• MDR Text Key: 136611224
• Report Number: 3011268530-2019-00004
• Device Sequence Number: 1
• Product Code: PCD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 01/20/2020

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 950PLUS
• Was Device Available for Evaluation?: Yes
• Device Age: 4 YR
• Event Location: Home
• Initial Date Manufacturer Received: 12/01/2017
• Initial Date FDA Received: 01/31/2019
• Supplement Dates Manufacturer Received: 12/01/2017
• Supplement Dates FDA Received: 01/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1