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

Model Number 180 T565

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 06/29/2022

Event Type  Injury  

Manufacturer Narrative

Attachments: signed investigation report; work completion report.

Event Description

On (b)(6) 2022, the customer's wife contacted acorn stairlifts, inc.Requesting that the stairlift be modified for her husband due to his health condition changing.He had become an amputee, loss of his leg, within the last year.She stated that on (b)(6) 2022, her husband had fallen on the landing and sustained a broken ankle.She communicated his account: "he has one leg, he was trying to get off the stairlift and had to get on his wheelchair but he lost the balance on the one leg he has and he completely fell.He broke his ankle and we had to call the ambulance to go to the hospital.So he's in the hospital now.".

• Brand Name: ACORN 180 T565 LH USA
• 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: 15133533
• MDR Text Key: 296915534
• Report Number: 3003124453-2022-00007
• Device Sequence Number: 1
• Product Code: PCD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 07/29/2022

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: 180 T565
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/29/2022
• Initial Date FDA Received: 07/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2021
• 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
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 75 KG