MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-03-02 for ACORN 130 RH manufactured by Acorn Stairlifts, Inc..
[68839782]
Stairlift stopped on descent because it hit an obstruction. User was not wearing seatbelt and failed to swivel the seat to safely dismount. User's son reported that the user fell and sustained broken lumbar and bruises.
Patient Sequence No: 1, Text Type: N, H10
[68839783]
Client was using the lift in the downward direction when the lift hit an obstruction causing safety edge to activate and stop lift. Client was not wearing seatbelt and did not swivel the chair to come out of the lift safely. Client missed a step and fell onto the kitchen floor. Client's son reported that the client broke his lumbar and sustained bruises; however, no evidence of these injuries were reported or visible upon investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003124453-2017-00004 |
| MDR Report Key | 6373200 |
| Report Source | CONSUMER |
| Date Received | 2017-03-02 |
| Date of Report | 2017-03-01 |
| Date of Event | 2017-01-25 |
| Date Mfgr Received | 2017-02-03 |
| Device Manufacturer Date | 2016-08-30 |
| Date Added to Maude | 2017-03-02 |
| 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 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| 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 | 4072308879 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACORN 130 RH |
| Generic Name | POWERED STAIRWAY CHAIRLIFT |
| Product Code | PCD |
| Date Received | 2017-03-02 |
| 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 | 2017-03-02 |