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

Model Number 1100

Device Problem Unintended System Motion (1430)

Patient Problem Bruise/Contusion (1754)

Event Date 08/09/2023

Event Type  Injury  

Manufacturer Narrative

Unit was inspected on site.Rail was very well lubricated, an indication that additional lubricant was applied by end user.The entire system (seat connected to the rail) was returned to the manufacturer for investigation.

Event Description

Customer (72) was attempting to sit on the unit, and powerpack/chair slide down the rail, ejecting customer.Brother downstairs called an ambulance to go to hospital.Customer had cuts/bruises.No internal bleeding/broken bones.Major bruising/swelling on back, bad shoulder, but is healing up.Customer was in hospital for 2 days then admitted to rehab for 2 weeks.

• Brand Name: HANDICARE 1100
• Type of Device: STAIR CHAIR LIFT
• Manufacturer (Section D): HANDICARE STAIRLIFTS B.V.; newtonstraat 35 p.o. box 39; heerhugowaard nl-nh, noord-holland 1700 AA N; NL 1700 AA NL
• MDR Report Key: 17837366
• MDR Text Key: 324515452
• Report Number: 1041130-2023-00003
• Device Sequence Number: 1
• Product Code: PCD
• UDI-Device Identifier: 8719326254326
• UDI-Public: (01)8719326254326
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 1100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2023
• Distributor Facility Aware Date: 09/14/2023
• Event Location: Home
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/28/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male