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

Model Number 180 T565 RH USA

Device Problems Electrical /Electronic Property Problem (1198); Battery Problem (2885); Connection Problem (2900)

Patient Problems Bone Fracture(s) (1870); Head Injury (1879); Laceration(s) (1946)

Event Date 12/20/2021

Event Type  Injury  

Event Description

On (b)(6) 2023, the client called acorn stairlifts, inc.And communicated that her stairlift was rocking during with a j4 code.The stairlift was serviced on 1/5/2023.On (b)(6) 2023, the client called to communicate that her stairlift was intermittently stopping.In this communication, the client stated that her husband had fallen coming down the stairs with multiple items in his hands that included her cpap machine.His failed resulted in a broken rib and 10 staples and 20 stitches in his forehead.He had landed on the cpap machine when he fell.She stated that had the stairlift been working, he could have used it instead of walking the stairs.The acorn representative asked when this incident had occurred.She stated she believed it was (b)(6) but was not fully certain.She had called for service on (b)(6) and the service was scheduled for (b)(6) 2022.The acorn customer representative asked to speak with her husband to see if he could get a detailed account of the incident.His account: "we have a staircase that comes down and makes a sharp right hand turn and i was carrying the c-pap machine, the so-clean and a couple other things down.Somehow i missed a step on the turn and took a nose dive.".

• Brand Name: ACORN
• 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: 16269425
• MDR Text Key: 308441783
• Report Number: 3003124453-2023-00006
• Device Sequence Number: 1
• Product Code: PCD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA#S-P#NA
• 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: 01/30/2023

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 RH USA
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/06/2023
• Initial Date FDA Received: 01/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2019
• 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): Required Intervention; Hospitalization; Other
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Weight: 84 KG