MAUDE Adverse Event Report: ACORN STAIRLIFTS, INC. ACORN 180 T565; POWERED STAIRLIFT CHAIR LIFT

Model Number 180 T565

Device Problems Loose or Intermittent Connection (1371); Incomplete or Inadequate Connection (4037)

Patient Problems Laceration(s) (1946); Neck Pain (2433); Vertebral Fracture (4520)

Event Date 12/12/2022

Event Type  Injury  

Event Description

Rider was riding the stairlift downstairs when the stairlift stopped mid-rail.She got out of the stairlift and fell down the remaining stairs.The client stated during the interview that she is not exactly sure of how she fell.The initial caller stated that the stairlift was still operational however the rider got impatient and tried to take the steps.She lost her footing and fell down the remainder of the stairs.The fall resulted in a broken neck and stitches in her forehead.

• Brand Name: ACORN 180 T565
• Type of Device: POWERED STAIRLIFT CHAIR LIFT
• Manufacturer (Section D): ACORN STAIRLIFTS, INC.; 7001 lake ellenor drive; orlando FL 32809
• Manufacturer (Section G): ACORN STAIRLIFTS, INC.; 7001 lake ellenor drive; orlando FL 32809
• Manufacturer Contact: melissa field ; 7001 lake ellenor drive; orlando, FL 32809 ; 4076500216
• MDR Report Key: 16221572
• MDR Text Key: 307879889
• Report Number: 3003124453-2023-00003
• Device Sequence Number: 1
• Product Code: PCD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A#S-P#N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 01/13/2023

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: 180 T565
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/20/2022
• Initial Date FDA Received: 01/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Other
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 52 KG