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

Model Number RET 130

Device Problem Use of Device Problem (1670)

Patient Problem Bone Fracture(s) (1870)

Event Date 09/01/2022

Event Type  Injury  

Event Description

(b)(6) 2022, the customer called acorn stairlifts, inc.For service on the stairlift.In the communication, the customer reported that thte stairlift moves before she is fuly seated onto the lift; she reported that in one occurrence that the stairlift started to move downward before she was seated.In response she lept off of the stairlift fearing she would fall.In that process.She stumbled and fell forward onto the upstairs floor resulting in a broken left ankle.

• Brand Name: RET 130 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: 15492148
• MDR Text Key: 300637878
• Report Number: 3003124453-2022-00015
• 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

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: RET 130
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/01/2022
• Initial Date FDA Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2015
• 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): Required Intervention; Other
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 91 KG