MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-07 for 130 ACORN T700 RH manufactured by Acorn Stairlifts, Inc..
[174859778]
The root cause of the injury was due to the employee not following proper lockout tag out protocol as outlined in the company's internal procedures. Before placing his hand back inside the unit it should have been powered down. The employee was trained on (b)(6) 2018 and his training records showed that he passed the assessment and fully understood the company's protocol. The employee was in a rush that day because he started his day behind schedule and was trying to makeup time to get to his next job. He believed he could quickly remove the screw within the carriage and failed to power down the unit. The employee will receive refresher training on the company's internal lockout tag out procedure. Lockout tag out training will become mandatory reoccurring training for all field technicians every three years.
Patient Sequence No: 1, Text Type: N, H10
[174859779]
On (b)(6) 2019, an employee was servicing an acorn 130 lift at the home of a customer. The lift was displaying an f1 code (relay fault) and it was determined the pcb needed to be replacement. Unit was powered down and the pcb was removed and replaced. After replacing the pcb, the unit was powered up and tested. While driving the lift up the employee heard a noise due to a screw falling out of the pcb. The screw fell between the chassis and the bottom roller. The employee removed the bottom safety cover, without powering the unit down, reached inside with his left hand to grab the screw. As he was reaching inside simultaneously, his left elbow was on the stairlift remote that he had left on the staircase. The employee did not hear the audible warning that the remote had engaged the chair and the unit moved pinching his finger between the motor gear and the racking on the stairlift rail. This caused a gash in the top of his finger that injured both sides and required stitches on the pad side and the removal of his fingernail.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003124453-2020-00002 |
| MDR Report Key | 9559475 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-07 |
| Date of Report | 2020-01-07 |
| Date of Event | 2019-12-09 |
| Date Mfgr Received | 2019-12-09 |
| Device Manufacturer Date | 2018-01-02 |
| Date Added to Maude | 2020-01-07 |
| 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 | MS. DORIAN PEARSON-SHAVER |
| Manufacturer Street | 7001 LAKE ELLENOR DRIVE |
| Manufacturer City | ORLANDO FL 32809 |
| Manufacturer Country | US |
| Manufacturer Postal | 32809 |
| Manufacturer Phone | 4076500216 |
| Manufacturer G1 | ACORN STAIRLIFTS, INC. |
| Manufacturer Street | 7001 LAKE ELLENOR DRIVE |
| Manufacturer City | ORLANDO FL 32809 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32809 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 130 ACORN T700 RH |
| Generic Name | POWER STAIRWAY CHAIR LIFT |
| Product Code | PCD |
| Date Received | 2020-01-07 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACORN STAIRLIFTS, INC. |
| Manufacturer Address | 7001 LAKE ELLENOR DRIVE ORLANDO FL 32809 US 32809 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-01-07 |