MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-04-21 for ACORN 180 RH manufactured by Acorn Stairlifts, Inc..
[73377174]
Found lift at bottom charge properly charging. Seatbelt was tangled, took seatbelt housing apart to ensure no damage to spring mechanism and untangled belt. All other components inspected to specification with exception of anti-tilt roller assembly which was broken but did not affect lift operation.
Patient Sequence No: 1, Text Type: N, H10
[73377175]
Client was riding lift in upward direction and fell out when going around the curve. Client not wearing seatbelt as it was stuck. Broke her wrist and clavicle.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003124453-2017-00006 |
| MDR Report Key | 6511664 |
| Report Source | CONSUMER |
| Date Received | 2017-04-21 |
| Date of Report | 2017-04-21 |
| Date of Event | 2017-03-13 |
| Date Mfgr Received | 2017-03-23 |
| Device Manufacturer Date | 2015-08-03 |
| Date Added to Maude | 2017-04-21 |
| 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 | 7001 LAKE ELLENOR DRIVE |
| Manufacturer City | ORLANDO FL 32809 |
| Manufacturer Country | US |
| Manufacturer Postal | 32809 |
| Manufacturer Phone | 4076500216 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACORN 180 RH |
| Generic Name | POWERED STAIRWAY CHAIRLIFT |
| Product Code | PCD |
| Date Received | 2017-04-21 |
| Returned To Mfg | 2017-03-28 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| 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 | 2017-04-21 |