MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-02-22 for ACORN 180 T565 RH manufactured by Acorn Stairlifts, Inc..
[136934200]
On (b)(6) 2019, the customer rode the lift downstairs. After leaving the kitchen, the customer went to ride the lift back upstairs but the lift would not operate. The customer attempted to troubleshoot the lift but was unsuccessful. The customer decided to walk the stairs unassisted and when he arrived at the top step, he fell backwards down the stairs. The customer's wife called 911 and the customer was taken to the hospital where he was diagnosed with a fractured vertebrae. The customer called acorn's office on january 24, 2019 to get the stairlift repaired. On january 26, 2019, acorn sent a technician to the residence to complete an investigation of the incident and repair the lift as needed. The technician determined that the lift was not properly charging likely due to the transformer being unplugged for several weeks while the residence was under construction. Loss of power to the lift caused the batteries to deplete which then caused the lift to lose programming. Loss of programming will cause the lift to stop after reaching the next charging station; however, since the charging station was not charging properly, the lift stopped at the lower final limit. The technician re-charged the batteries and reprogrammed the lift. He then provided a full demonstration of the stairlift usage and reminded the customer that the lift must have ac power at all times to ensure proper charging.
Patient Sequence No: 1, Text Type: N, H10
[136934201]
Customer rode lift downstairs to go to the kitchen. When the customer went to travel back up stairs, the lift would not operate. Customer attempted to troubleshoot on his own but was unsuccessful. Customer decided to walk the stairs, unassisted, and fell backwards when he reached the top step. Customer was taken to the hospital and suffered fractures to his vertebrae.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003124453-2019-00001 |
| MDR Report Key | 8364025 |
| Report Source | CONSUMER |
| Date Received | 2019-02-22 |
| Date of Report | 2019-02-22 |
| Date of Event | 2019-01-04 |
| Date Mfgr Received | 2019-01-24 |
| Device Manufacturer Date | 2017-03-21 |
| Date Added to Maude | 2019-02-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | TRACY BERO |
| Manufacturer Street | 7001 LAKE ELLENOR DRIVE |
| Manufacturer City | ORLANDO FL 328095792 |
| Manufacturer Country | US |
| Manufacturer Postal | 328095792 |
| Manufacturer Phone | 4072308879 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACORN 180 T565 RH |
| Generic Name | POWERED STAIRWAY CHAIRLIFT |
| Product Code | PCD |
| Date Received | 2019-02-22 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACORN STAIRLIFTS, INC. |
| Manufacturer Address | 7001 LAKE ELLENOR DRIVE ORLANDO FL 328095792 US 328095792 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-02-22 |