MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2016-12-19 for ACORN 180 RH manufactured by Acorn Stairlifts, Inc..
[62786034]
Client has polio and wears a leg brace on left leg which was broken in fall. Caregiver reminded to tell user to wear seatbelt at all times when using lift and to have assistance with use. Technician damaged osg during repair, so new osg fitted. Lift repaired and operating to spec.
Patient Sequence No: 1, Text Type: N, H10
[62786035]
Upon descent, lift stopped at landing. Client tried to get off lift and fell down two steps and broke her left leg on which she wears a brace due to polio.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003124453-2016-00008 |
| MDR Report Key | 6187380 |
| Report Source | OTHER |
| Date Received | 2016-12-19 |
| Date of Report | 2016-12-09 |
| Date of Event | 2016-11-05 |
| Date Mfgr Received | 2016-11-11 |
| Device Manufacturer Date | 2011-10-29 |
| Date Added to Maude | 2016-12-19 |
| 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 | MS. TRACY BERO |
| Manufacturer Street | 7001 LAKE ELLENOR DRIVE |
| Manufacturer City | ORLANDO FL 32809 |
| Manufacturer Country | US |
| Manufacturer Postal | 32809 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACORN 180 RH |
| Generic Name | STAIRWAY CHAIRLIFT, |
| Product Code | PCD |
| Date Received | 2016-12-19 |
| 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 32809 US 32809 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2016-12-19 |