MAUDE Adverse Event Report: HANDICARE ACCESSIBILITY UK LTD HANDICARE STAIRLIFTS 2000

Device Problems Failure to Auto Stop (2938); Protective Measures Problem (3015)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2017

Event Type  malfunction  

Manufacturer Narrative

Filing retrospective medical device reports.

Event Description

On (b)(6) 2017, the user called to and informed that the lift came off the track.It looks as though the end stops and final stop failed.When the lift was removed from the track the final limit switch in the trunnion failed, switch assy and bars are bent now but that was because of impact damage on (b)(6) 2018 the mechanical end stop of the rail has come off.The stairlift was not in use while the incident occured and no injuries reported on both incidents.

Event Description

On 29/11/2017, the user called to and informed that the lift came off the track.It looks as though the end stops and final stop failed.When the lift was removed from the track the final limit switch in the trunnion failed, switch assy and bars are bent now but that was because of impact damage.On 16/07/2018 the mechanical end stop of the rail has come off.The stairlift was not in use while the incident occured and no injuries reported on both incidents.

Manufacturer Narrative

38,793 end stops supplied from oct 16 - jan 19 and 3 reported failures from oct 16 - jan 19 at the component failure rate of : 0.008% it is suspected that the trunnion has repetitively knocked against the end stop which over time has weakened the weld and the weld eventually failed.Correction: july 2018 a new universal end stop was launched.Further improvements are being made under the same ecn to improve fitness.All recorded failures of the end stops are with the old designs made prior to july 2018.25 production samples of the universal end stop were tested and they successfully stopped the power pack loaded with 342.5kg with all electrical safeties removed.The welding was inspected by r&d and quality.Further testing was performed on the universal end stop over 66,530 cycles and passed with no reported issues.All reported failures have occured with an older design.Manufacturer introduced the universal end sto in july 2018 and failures are reported.

• Brand Name: HANDICARE STAIRLIFTS 2000
• Type of Device: STAIRLIFT
• Manufacturer (Section D): HANDICARE ACCESSIBILITY UK LTD; 82 first avenue; pensnett estate; kingswinford dudley, DY6 7 FJ; UK DY6 7FJ
• MDR Report Key: 8292779
• MDR Text Key: 136991783
• Report Number: 3011268530-2019-00003
• 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,distri
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/21/2019
• Device Age: 12 YR
• Event Location: Home
• Initial Date Manufacturer Received: 11/27/2017
• Initial Date FDA Received: 01/31/2019
• Supplement Dates Manufacturer Received: 11/27/2017
• Supplement Dates FDA Received: 01/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1