MAUDE Adverse Event Report: HANDICARE STAIRLIFTS B.V FREECURVE; CHAIR LIFT

Model Number C0020091

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/29/2020

Event Type  malfunction  

Manufacturer Narrative

Handicare, the importer, notified the manufacturer, handicare stairlifts bv, of the incident on (b)(6) 2020.This unit has not yet been returned.When received, it will be sent to handicare stairlifts bv for investigation.A follow-up report will be submitted with the findings of the investigation.

Event Description

During the initial test ride by the dealer prior to signing off the lift to the customer, the chair tilted more than 90 degrees.The dealer was riding in the up direction at the time, and was able to catch himself to prevent a fall.The dealer replaced the powerpack with a new unit which successfully passed all tests.

• Brand Name: FREECURVE
• Type of Device: CHAIR LIFT
• Manufacturer (Section D): HANDICARE STAIRLIFTS B.V; newtonstraat 35; p.o. box 39; heerhugowaard, noord-holland 1700 AA; NL 1700 AA
• Manufacturer (Section G): HANDICARE STAIRLIFTS B.V; newtonstraat 35; p.o. box 39; heerhugowaard, noord-holland 1700 AA; NL 1700 AA
• Manufacturer Contact: jan hopman ; newtonstraat 35; p.o. box 39; heerhugowaard, noord-holland 1700 -AA ; NL 1700 AA
• MDR Report Key: 10843045
• MDR Text Key: 216375299
• Report Number: 3013423626-2020-00023
• 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,foreig
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 11/16/2020

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: Other
• Device Model Number: C0020091
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/30/2020
• Initial Date FDA Received: 11/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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