MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2019-01-31 for HANIDCARE STAIRLIFTS 950PLUS manufactured by Handicare Accessibility Uk Ltd.
[136611224]
Filing retrospective medical device reports.
Patient Sequence No: 1, Text Type: N, H10
[136611305]
The seat toggle stuck the user and she was trying to get on the lift and it moved. She fell, cut her arm and brought her down the stairs on her back. User slid off the seat down the side of it and the lift continued to move going down. User wedged down the side and it started to drag her down on her back, user screamed and a lady in the house tried to help, while the lift was about half way down. The lift was stopped by the customer throwing her arm up to knock the stairlift arms up as she's aware that cuts the lift out. This is what we believe think caused the cut on her arm. The lift was moving by itself up to a week before the incident, but in the last couple weeks customer told son that if you push the lift to go down and let go it carried on going, and the son saw this for himself at a later date. An engineer had gone out to change the battery and the tightened the toggle, it didn't spring back 100 % instantly as it should, and it was still a bit slack. The engineer also mentioned that the safety device whereby if you lift the arm up it cuts the lift hadn't been connected it had been connected before this incident. The user was bruised all over but was not hospitalized.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011268530-2019-00004 |
| MDR Report Key | 8292942 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2019-01-31 |
| Date of Report | 2019-01-31 |
| Date of Event | 2017-12-01 |
| Date Mfgr Received | 2017-12-01 |
| Date Added to Maude | 2019-01-31 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ANDREW WILLIAMS |
| Manufacturer Street | 82 FIRST AVENUE PENSNETT ESTATE |
| Manufacturer City | KINGSWINFORD DUDLEY, WEST MIDLANDS DY6 7FJ |
| Manufacturer Country | UK |
| Manufacturer Postal | DY6 7FJ |
| Manufacturer G1 | HANDICARE ACCESSIBILITY UK LTD |
| Manufacturer Street | 82 FIRST AVENUE PENSNETT ESTATE |
| Manufacturer City | KINGSWINFORD DUDLEY, WEST MIDLANDS DY6 7FJ |
| Manufacturer Country | UK |
| Manufacturer Postal Code | DY6 7FJ |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HANIDCARE STAIRLIFTS |
| Generic Name | STAIRLIFTS |
| Product Code | PCD |
| Date Received | 2019-01-31 |
| Model Number | 950PLUS |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HANDICARE ACCESSIBILITY UK LTD |
| Manufacturer Address | 82 FIRST AVENUE PENSNETT ESTATE KINGSWINFORD DUDLEY, WEST MIDLANDS DY6 7FJ UK DY6 7FJ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-31 |