MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-02-02 for ACORN 180 LH manufactured by Acorn Stairlifts, Inc..
[98915729]
On (b)(6) 2017 the customer attempted to ride the stairlift to go upstairs but the unit would not move from its position at the bottom charge point. After trying to use the lift the customer attempted to walk up the stairs. On the second step up from the mid-landing she lost her footing and fell backwards down the stairs to the foyer. The fall resulted in multiple injuries. The incident occurred on (b)(6) 2017 but was not reported to acorn until (b)(6) 2018. Between those two dates the lift was unmoved but was turned off by the customer's son-in-law to stop the beeping. The lift was off and uncharged for several months; because of this the root cause could not be adequately determined. The most likely underlying cause was the excess lubricant on the charge pins. The dirt buildup that resulted from the excess lubricant caused continuity issues within the charging circuit so the lift would not charge properly rendering it inoperable. During the (b)(6) 2018 product evaluation; the excess lubricant was removed and the charge pins were cleaned and re-greased. The carriage was also replaced as a courtesy and so acorn could further evaluate the equipment.
Patient Sequence No: 1, Text Type: N, H10
[98915730]
The customer attempted to use the lift to go upstairs, but was not able to get the lift to move off the bottom charge point. There was too much lubricant on the charge pins preventing the lift from fully charging. The customer decided to walk up the stairs since the lift was not working. When she reached the second landing she lost her footing and fell down the stairs to the foyer. The fall resulted in multiple injuries.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003124453-2018-00001 |
| MDR Report Key | 7238415 |
| Report Source | CONSUMER |
| Date Received | 2018-02-02 |
| Date of Report | 2018-02-02 |
| Date of Event | 2017-10-18 |
| Date Mfgr Received | 2018-01-03 |
| Device Manufacturer Date | 2015-12-28 |
| Date Added to Maude | 2018-02-02 |
| 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 | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACORN 180 LH |
| Generic Name | POWER STAIRWAY CHAIRLIFT |
| Product Code | PCD |
| Date Received | 2018-02-02 |
| 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 | 2018-02-02 |