MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-04-28 for ACORN 130 LH manufactured by Acorn Stairlifts, Inc..
[73975221]
At time of install demo was provided to client's husband since client was in rehab following a previous fall. When client returned from rehab, a visit was scheduled to demo to client herself. Prior to the date of the scheduled demo, client tried to use the stairlift without following instructions and when she reached the top of the steps she unfastened the seatbelt and tried to swivel the seat but fell out in the process. There were inconsistencies in the description of events provided by clients husband initially. Acorn was able to speak personally with the client (b)(6) 2017.
Patient Sequence No: 1, Text Type: N, H10
[73975222]
Client's husband was given demo and instructions for use on day of install. Client was still in rehab from a previous fall. Technician returned to the home when client was released from rehab in order to demo to client. Client's husband informed the technician that his wife had fallen down the stairs but he was unsure if the stairlift was being used at the time. Client broke leg and shoulder.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003124453-2017-00007 |
| MDR Report Key | 6531031 |
| Report Source | CONSUMER |
| Date Received | 2017-04-28 |
| Date of Report | 2017-04-28 |
| Date of Event | 2017-02-23 |
| Date Mfgr Received | 2017-02-27 |
| Device Manufacturer Date | 2016-08-16 |
| Date Added to Maude | 2017-04-28 |
| 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 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| 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 32809 |
| Manufacturer Country | US |
| Manufacturer Postal | 32809 |
| Manufacturer Phone | 4076500216 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACORN 130 LH |
| Generic Name | POWERED STAIRWAY CHAIRLIFT |
| Product Code | PCD |
| Date Received | 2017-04-28 |
| 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 32809 US 32809 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2017-04-28 |