MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2019-01-31 for HANDICARE STAIRLIFTS manufactured by Handicare Accessibility Uk Ltd.
[136991783]
Filing retrospective medical device reports.
Patient Sequence No: 1, Text Type: N, H10
[136991784]
On (b)(6) 2017, the user called to and informed that the lift came off the track. It looks as though the end stops and final stop failed. When the lift was removed from the track the final limit switch in the trunnion failed, switch assy and bars are bent now but that was because of impact damage on (b)(6) 2018 the mechanical end stop of the rail has come off. The stairlift was not in use while the incident occured and no injuries reported on both incidents.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011268530-2019-00003 |
| MDR Report Key | 8292779 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-01-31 |
| Date of Report | 2019-01-31 |
| Date of Event | 2017-11-29 |
| Date Facility Aware | 2019-01-21 |
| Date Mfgr Received | 2017-11-27 |
| Device Manufacturer Date | 2007-07-30 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| 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 | HANDICARE STAIRLIFTS |
| Generic Name | STAIRLIFT |
| Product Code | PCD |
| Date Received | 2019-01-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 12 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 |