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

Model Number 130 T700

Device Problem Failure to Run on Battery (1466)

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

Event Date 07/11/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, acorn stairlifts, inc.Was contacted by the user to request service for the stairlift due to the stairlift not operating.The report was that there was an h5 (memory not responding) code.A service ticket was initiated for the scheduling team to schedule service because acorn was not able to schedule service on (b)(6) 2022.On (b)(6) 2022, the user contacted acorn to inquire about the scheduled service date.He communicated to acorn that since the date that he first contacted acorn, he had used the stairs and he had fallen down the stairs resulting in a broken left wrist and head contusions.The user was not able to recall the exact date of the incident but that it did occur between (b)(6) 2022.

• Brand Name: 130 ACORN T700 RH USA
• Type of Device: POWERED STAIRWAY CHAIR LIFT
• Manufacturer (Section D): ACORN STAIRLIFTS, INC.; 7001 lake ellenor drive; orlando OH 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: 15198399
• MDR Text Key: 297590691
• Report Number: 3003124453-2022-00009
• 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: Replace
• Type of Report: Initial
• Report Date: 08/08/2022

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: 07/11/2022
• Initial Date FDA Received: 08/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2019
• 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): Other; Required Intervention
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Ethnicity: Hispanic