MAUDE Adverse Event Report: HANDICARE 2000 OUTDOOR; OUTDOOR STAIRLIFT

Device Problems Break (1069); Detachment Of Device Component (1104); Installation-Related Problem (2965); Misassembled During Installation (4049)

Patient Problems Fall (1848); Head Injury (1879); Laceration(s) (1946); Injury (2348)

Event Date 03/21/2018

Event Type  Injury  

Manufacturer Narrative

Outcome of investigation is pending.A final report will be submitted upon completion.

Event Description

An end user was sitting in the chair seat of a 2000 outdoor stairlift and while in motion, the chair seat broke away from the rail.The end user tumbled down the stairway.Following the fall he had a gash on his head, hurt his arm, and his legs.He went to an urgent care facility for attention.He was treated for his injuries and was home the same day.

Manufacturer Narrative

Handicare accessibility (b)(6), the manufacturer of 2000 series outdoor, sn (b)(4) has completed their investigation into the incident.The manufacturer has performed a full review of the pictures provided from the installation as well as disassembly of the power pack for inspection of internal components.In addition, the trunnion casting was sent for external material analysis by a metallurgical laboratory.Their conclusion is that the pack was misloaded during installation and subsequent reinstallation.The resulting misalignment and excessive forces over time caused a stress fracture of the trunnion casting, resulting in the incident.They also noted that because the installation contains no horizontal rail segments great care would be needed on the part of the installer to avoid a misalignment.Dealer and installer are communicated to reinforce the importance of making sure that the pack is correctly loaded as described in the installation manuals.

• Brand Name: 2000 OUTDOOR
• Type of Device: OUTDOOR STAIRLIFT
• Manufacturer (Section D): HANDICARE; 82 first avenue; pensnett estate; kingswinford, DY6 7 FJ; UK DY6 7FJ
• MDR Report Key: 7443160
• MDR Text Key: 106625376
• Report Number: 3011268530-2018-00016
• 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: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Weight: 88