MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-04-12 for ACORN 130 manufactured by Acorn Stairlifts, Inc..
[141795718]
On (b)(6) 2019 the customer rode the stairlift upstairs. Three fourths of the way up, the lift stopped and would not move. The customer dismounted the lift and attempted to walk back down the stairs when he slipped. In an attempt to grab the chair to stop the fall, the customer fell backwards down the stairs, hitting the left side of his head against the wall. The customer suffered a laceration to his ear which required stitches. On (b)(6) 2019, a technician was sent to the residence to complete an inspection. It was found that packing oil had been leaking from the motor which caused the motor to fail. The motor caused over amping of the power which then blew the fuse which caused the lift to stop operating. The root cause of the leak could not be determined during the initial inspection. Most likely underlying cause of motor oil leak is gasket failure at the lower housing seal. After inspection was complete, acorn shipped the carriage and motor back to the office in (b)(6) via ups. Ups has notified acorn that the package containing the motor was lost in transit. If the package is recovered, acorn will provide a supplemental investigation report.
Patient Sequence No: 1, Text Type: N, H10
[141795719]
Customer was riding the stairlift upstairs when the lift stopped 3/4 of the way up. The customer dismounted the lift and attempted to walk back down the steps when he slipped. He tried to turn his body and grab hold of the chair but fell backwards down the remaining steps. He hit the left side of his head against the wall and suffered injury to his ear.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003124453-2019-00002 |
| MDR Report Key | 8510316 |
| Report Source | CONSUMER |
| Date Received | 2019-04-12 |
| Date of Report | 2019-04-12 |
| Date of Event | 2019-03-12 |
| Date Mfgr Received | 2019-03-12 |
| Device Manufacturer Date | 2014-01-29 |
| Date Added to Maude | 2019-04-12 |
| 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 | TRACY BERO |
| Manufacturer Street | 7001 LAKE ELLENOR DR. |
| Manufacturer City | ORLANDO FL 328095792 |
| Manufacturer Country | US |
| Manufacturer Postal | 328095792 |
| Manufacturer Phone | 4076500216 |
| Manufacturer G1 | ACORN STAIRLIFTS, INC. |
| Manufacturer Street | 7001 LAKE ELLENOR DR. |
| Manufacturer City | ORLANDO FL 328091764 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 328091764 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACORN 130 |
| Generic Name | POWERED STAIRWAY CHAIRLIFT |
| Product Code | PCD |
| Date Received | 2019-04-12 |
| 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 DR ORLANDO FL 328095792 US 328095792 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-04-12 |