MAUDE Adverse Event Report: ACORN STAIRLIFTS, INC. 130 ACORN T700; POWERED STAIRWAY CHAIR LIFT

Model Number 130 T700

Device Problem Use of Device Problem (1670)

Patient Problem Vertebral Fracture (4520)

Event Date 09/13/2022

Event Type  Injury  

Event Description

The client was interviewed by acorn stairlift's technician on (b)(6) 2022.The rider communicated that she was riding the stairlift while carrying multiple items on her lap.As she operated the stairlift upwards, onbe of the items fell from her lap, she reacted by leaning to try and catch it.She fell out of the stairlift resulting in a serious injury of c1 nondisplaced fracture.It was found in the interview that the rider was not using the seatbelt as required for safe use of the stairlift.

Manufacturer Narrative

Preventative action: additional training to the client on intended use and safe operation of the stairlift.Specifically, do not carry items on the stairlift when riding and use the seatbelt when using the stairlift as instructed in the user manual.

• Brand Name: 130 ACORN T700
• Type of Device: POWERED STAIRWAY 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: 15534460
• MDR Text Key: 301085028
• Report Number: 3003124453-2022-00016
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 10/03/2022

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: 130 T700
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/13/2022
• Initial Date FDA Received: 10/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 91 KG