MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-03 for 130 ACORN RH manufactured by Acorn Stairlifts, Inc..
[178532495]
Ems called acorn starilifts, inc. Customer support on 12/5/2019 and asked us how to hand wind the stairlift to the top of the rail so the stairlift would clear egress to transport the user down the stairs. The stairlift was installed on 4/19/2011. The stairlift has had an annual service inspection once a year since 2016 on the following dates 6/6/2016, 5/19/2017, 6/12/2018, and 8/23/2019. On (b)(6) 2019 the client reported the stairlift running slow and the batteries were replaced. Until (b)(6) 2019, the stairlift has been working with no incidents reported continuously since (b)(6) 2011. At this time root cause can't be determined as it is not currently possible to reconstruct what caused the user's knees to make contact with the wall. He is currently in rehab and unable to be measured and/or demonstrate what kept him from clearing the handrail. There were no reported ride quality or clearance issues prior to the incident on (b)(6) 2019. Only the staircase measurements are on file, the user's measurements are not documented and will have to be obtained on-site when the user has returned from rehab in late january/early february.
Patient Sequence No: 1, Text Type: N, H10
[178532496]
On (b)(6) 2019, the user's son called in to schedule service for his father (the user). The stairlift had stopped working during use. He stated that his father had used the stairlift to go upstairs and his knees were dragging against the wall; his left knee became trapped where the handrail attaches to the handrail bracket (3rd bracket from the bottom). The user continued to drive the stairlift up as his left foot pressed into the footrest causing an injury to his left ankle. It was at this point the stairlift quit working and the user was stuck with his left leg pinned between the footrest and the handrail. Ems was called to assist and remove the user from the stairlift. Ems took the handrail down to free the user's leg and transported him to get medical attention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003124453-2020-00001 |
| MDR Report Key | 9549482 |
| Report Source | CONSUMER |
| Date Received | 2020-01-03 |
| Date of Report | 2020-03-25 |
| Date of Event | 2019-12-05 |
| Date Mfgr Received | 2019-12-05 |
| Device Manufacturer Date | 2011-04-20 |
| Date Added to Maude | 2020-01-03 |
| 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 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 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 RH |
| Generic Name | POWER STAIRWAY CHAIR LIFT |
| Product Code | PCD |
| Date Received | 2020-01-03 |
| Device Availability | Y |
| Device Age | DA |
| 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 FL 32809 US 32809 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-01-03 |