MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-04-17 for ACORN MODEL 180 manufactured by Acorn Stairlifts, Inc.
[142271619]
Mrs. (b)(6) has not been available for questioning regarding the incident. Management has tried to contact her several times to no avail. Management was informed by the neighboring business that mrs. (b)(6) was still in rehab as of (b)(6) 2019. No estimated date of return. During investigation, the stairlift was found stopped in the middle of the track. Batteries were depleted. Root cause on why the stairlift was in the middle of the track could not be determined at this time. No information could be obtained on the nature of mrs. (b)(6)'s fall but out of an abundance of caution, an adverse event report is being filed. If acorn gets the opportunity to speak with mrs. (b)(6) and clarify details surrounding the incident, a supplemental report will be filed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[142271620]
Neighbor, (b)(6), called to have the lift serviced. He stated that mrs. (b)(6) was in rehab due to falling in the residence. He could not state with any certainty whether the lift caused or contributed to the fall or not as he was not present during the incident. Lift was found mid rail.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003124453-2019-00003 |
| MDR Report Key | 8524675 |
| Report Source | CONSUMER |
| Date Received | 2019-04-17 |
| Date of Report | 2019-04-17 |
| Date of Event | 2019-03-08 |
| Date Mfgr Received | 2019-03-18 |
| Device Manufacturer Date | 2018-11-07 |
| Date Added to Maude | 2019-04-17 |
| 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 | TRACY BERO |
| Manufacturer Street | 7001 LAKE ELLENOR DRIVE |
| Manufacturer City | ORLANDO FL 328095792 |
| Manufacturer Country | US |
| Manufacturer Postal | 328095792 |
| 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 | ACORN MODEL 180 |
| Generic Name | POWERED STAIRWAY CHAIRLIFT |
| Product Code | PCD |
| Date Received | 2019-04-17 |
| 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 328095792 US 328095792 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-04-17 |