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

Device Problems Fail-Safe Problem (2936); Fail-Safe Did Not Operate (4046)

Patient Problems Bruise/Contusion (1754); Fall (1848)

Event Date 06/05/2018

Event Type  malfunction  

Manufacturer Narrative

Retrospective medical device reporting.

Event Description

When tap to floor was used by the customer on the freecurve in combination with a hinge rail, it occurred that the freecurve unit did not stop at the hinge rail.The customer was most likely not wearing a seat belt, customer said she fell forward a bit, more of a jerk and bruised her arm.Policy would be that tap to floor option is "manually" switched off in the software of the powerpack configurator if a hinge rail configuration is used: however, it appears that this was not always done.

• Brand Name: FREECURVE
• Type of Device: STAIRLIFTS
• Manufacturer (Section D): HANDICARE STAIRLIFTS B.V; newtonstraat 35; p.o. box 39; heerhugowaard, 1700 AA; NL 1700 AA
• MDR Report Key: 8030467
• MDR Text Key: 125917089
• Report Number: 3007802293-2018-00042
• Device Sequence Number: 1
• Product Code: PCD
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/01/2018

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 the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/30/2018
• Device Age: 2 YR
• Event Location: Home
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1