MAUDE Adverse Event Report: SAVARIA CONCORD LIFTS INC STAIRFRIEND; CURVED STIAR CHAIR LIFT

Model Number CSL 3000

Device Problems Crack (1135); Nonstandard Device (1420); Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Date 02/24/2015

Event Type  malfunction  

Manufacturer Narrative

Total units effected in the united states 119.As of reporting april 1 2016 - 44 units remain not corrected.The following dates are contacts with dealers by phone and/or email to enforce the requirement to correct the welded part.Initial parts order and shipment date.February 25th 2015, february 26th 2015 ,february 27th 2015.Follow up for work completion date.On may 2015 - insure receipt and understanding of correction august 2015 - follow up non completed units.On september - 2015 follow up non completed units.December - 2015 follow up non completed units.Sales department following up on individual basis.

Event Description

During operation it was found that some of the seat post welds were not properly done and the weld would crack causing the seat to tilt.Once tilted the seat is unable to swivel and if not addressed the seat post weld would continue to crack eventually corning completely separated there is the potential for the user to fall possibly causing injury.

• Brand Name: STAIRFRIEND
• Type of Device: CURVED STIAR CHAIR LIFT
• Manufacturer (Section D): SAVARIA CONCORD LIFTS INC; 2 walker drive; brampton, ontario L6T5E 1; CA L6T5E1
• Manufacturer (Section G): SAVARIA CONCORD LIFTS INC; 2 walker drive; brampton, ontario L6T5E 1; CA L6T5E1
• Manufacturer Contact: william richardson ; 2 walker drive; brampton, ontario L6T5E-1 ; CA L6T5E1 ; 7995555
• MDR Report Key: 6554099
• MDR Text Key: 74909594
• Report Number: 3005753836-2016-00002
• Device Sequence Number: 1
• Product Code: PCD
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 02/23/2015,03/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CSL 3000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Date Report to Manufacturer: 02/23/2015
• Date Manufacturer Received: 02/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention