MAUDE Adverse Event Report: HANDICARE STAIRLIFTS B.V HANDICARE; 1100

Model Number 1100

Device Problem Fracture (1260)

Patient Problems Fall (1848); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

When the user was approximately half-way up the stairs, the seatbelt broke and the user fell from the seat.The user's father caught him, returned him to the seat, and continued the ride to the top of the stairs.The user was not injured.

• Brand Name: HANDICARE
• Type of Device: 1100
• Manufacturer (Section D): HANDICARE STAIRLIFTS B.V; newtonstraat 35; p.o. box 39; heerhugowaard, noord-holland 1700 AA; NL 1700 AA
• MDR Report Key: 10065631
• MDR Text Key: 191272669
• Report Number: 3007802293-2020-00009
• Device Sequence Number: 1
• Product Code: PCD
• UDI-Device Identifier: 08719326254326
• UDI-Public: (01)08719326254326(11)191021
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1100
• Device Catalogue Number: AA17359
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/18/2020
• Distributor Facility Aware Date: 04/24/2020
• Device Age: 6 MO
• Event Location: Home
• Date Report to Manufacturer: 05/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Weight: 95