MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-06-17 for ACORN 180 ACORN 180 LH manufactured by Acorn Stairlifts, Inc..
[47675513]
Daughter (b)(6) usually supervises user but did not on this occasion. (b)(6) was instructed how to lock out the lift to ensure mother does not use lift without supervision. Visit scheduled (b)(6) 2016 to see if any rail modifications are required.
Patient Sequence No: 1, Text Type: N, H10
[47675514]
Customer has dementia and syncope and usually has assistance when using the lift. On this occasion she tried to use the lift unaided and did not secure the seatbelt when riding the stairlift in the downward direction. Fell forward out of the lift and fell down several steps breaking her wrist.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003124453-2016-00001 |
| MDR Report Key | 5733378 |
| Report Source | CONSUMER |
| Date Received | 2016-06-17 |
| Date of Report | 2016-06-17 |
| Date of Event | 2016-05-15 |
| Date Mfgr Received | 2016-05-20 |
| Device Manufacturer Date | 2014-01-15 |
| Date Added to Maude | 2016-06-17 |
| 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 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. TRACY BERO |
| Manufacturer Street | 7001LAKE ELLENOR DRIVE |
| Manufacturer City | ORLANDO FL 32809 |
| Manufacturer Country | US |
| Manufacturer Postal | 32809 |
| Manufacturer Phone | 4076500216 |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACORN 180 |
| Generic Name | STAIRWAY CHAIRLIFT |
| Product Code | PCD |
| Date Received | 2016-06-17 |
| Model Number | ACORN 180 LH |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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. Required No Informationntervention | 2016-06-17 |