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

Device Problem Failure to Auto Stop (2938)

Patient Problems No Information (3190); No Code Available (3191)

Event Date 11/09/2017

Event Type  malfunction  

Manufacturer Narrative

Retrospective medical device reporting.

Event Description

Lift tilted sideways.Outgoing shaft could slip in the last gear in the gearbox.Investigation showed that where normally the pinion is pushed on the shaft, creating dents and a form fit, this was not the case in this gearbox.Most probably; therefore, the tolerances of the inner hole in the last gear were out of specification.Drawings are owned by (b)(4); supplier of the particular faulty gearbox.We requested feedback from (b)(4) multiple times regarding root cause analysis but so far handicare has received none.

• 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: 8030721
• MDR Text Key: 125905180
• Report Number: 3007802293-2018-00044
• Device Sequence Number: 1
• Product Code: PCD
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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 Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 11/01/2018
• 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