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

Model Number INTERNAL CURVE

Device Problems Break (1069); Solder Joint Fracture (2324); Failure to Auto Stop (2938); Material Integrity Problem (2978); Protective Measures Problem (3015)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2018

Event Type  malfunction  

Manufacturer Narrative

Retrospective mdr reporting.

Event Description

Mechanical end stop weld broke of the rail and the pack came off the rail.No injuries reported.

Manufacturer Narrative

(b)(4).Correction: july 2018, a new universal end stop was launched.Further improvements are being made under the same ecn to improve fitability.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.

Event Description

Mechanical end stop weld broke of the rail and the pack came off the rail.No injuries reported.

• Brand Name: HANDICARE STAIRLIFTS 2000
• 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: 8304644
• MDR Text Key: 134999084
• Report Number: 3011268530-2019-00005
• 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: Replace
• 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: No Information
• Device Model Number: INTERNAL CURVE
• Distributor Facility Aware Date: 02/05/2019
• Device Age: 1 YR
• Event Location: Home
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/05/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1