MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-10-08 for ACORN 130 RH manufactured by Acorn Stairlifts, Inc..
[123060763]
Indirect factor was improper training to 'free spin' the motor at the top of the rail by regional manager. This is not published protocol and while it is an acceptable redundancy to free spin the motor before running it onto the rail to ensure osg is not engaged, it is not included in the documented process when loading the carriage or completing an annual inspection. Contributing factor was regional manager not supervising employee during training session. The most likely underlying cause is improper hand position while loading the carriage. On 10/2/2018 while attending a senior executive meeting, the director of compliance become aware that an employee was involved in a mdr reportable incident.
Patient Sequence No: 1, Text Type: N, H10
[123060764]
During a training session, an employee was at a customer's home with an experienced technician and their regional manager. The employee loaded the 130 carriage onto the rail and went to run the carriage up the racking with the remote. The employee's left hand was holding roller axle, and he was preparing to check that the osg was operating correctly. He grabbed the remote and depressed what he thought was the up button, instead was the down button. The carriage proceeded down pinching his finger between the axle and the exposed rail, severing his finger tip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003124453-2018-00002 |
| MDR Report Key | 7942628 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-10-08 |
| Date of Report | 2018-10-08 |
| Date of Event | 2018-08-09 |
| Date Mfgr Received | 2018-08-09 |
| Device Manufacturer Date | 2017-08-29 |
| Date Added to Maude | 2018-10-08 |
| 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. TRACY BERO |
| Manufacturer Street | 7001 LAKE ELLENOR DRIVE |
| Manufacturer City | ORLANDO FL 328095792 |
| Manufacturer Country | US |
| Manufacturer Postal | 328095792 |
| Manufacturer Phone | 4076500216 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACORN 130 RH |
| Generic Name | POWER STAIRWAY CHAIRLIFT |
| Product Code | PCD |
| Date Received | 2018-10-08 |
| 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. Deathisabilit | 2018-10-08 |