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

Model Number 130

Device Problem Use of Device Problem (1670)

Patient Problems Bruise/Contusion (1754); Bone Fracture(s) (1870); Laceration(s) (1946)

Event Date 08/08/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, acorn stairlifts, inc.Was contacted by the customer and reported that the stairlift was not working.The customer communicated that her husband had attempted to use the stairlift at the top of the stairs however the stairlift would not operate.The error code displayed was an e2 code which signified that the safety edge was activated.He proceeded to get off of the stairlift to take the stairs and fell down the stairs from the second step from the top resulting in a broken wrist and bruises and cuts on his face and head.

• Brand Name: RET 130 ACORN LH US HEAVY DUTY
• 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: 15375061
• MDR Text Key: 299449328
• Report Number: 3003124453-2022-00012
• 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: Inspection
• Type of Report: Initial
• Report Date: 09/07/2022

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/08/2022
• Initial Date FDA Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2012
• 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; Other
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 120 KG