MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-11-30 for ACORN 180 LH manufactured by Acorn Stairlifts, Inc..
[93416757]
On 9/23/2016 the lift was installed by the tech to manufacturer's specifications. The customer called in on (b)(6) 2016 requesting rail alterations. The customer support agent who handled the (b)(6) 2016 call informed the customer the lift was installed to specifications; however, on 10/13/2016 a service call was scheduled. During the 10/24/2016 service visit the field technician stated, "customer is an engineer and wanted it done his way. " the tech moved the upper rail closer to the hand rail and reconfigured the bottom rail so the chair was farther away from the door, per the customer's request. The reconfiguration resulted in the bottom rail being 27 inches off the ground. The height of the bottom 180 wrap caused the pcb to lose it's spot on the rail. There was a breakdown scheduled on (b)(6) 2017 because the chair was out of level, the customer's son-in-law called the day of the appointment to cancel the visit. On (b)(6) 2017 the customer was using the lift going downstairs when the lift tilted and stopped. Since the rail was too high off the ground the customer and her husband had difficulty getting her off the seat, resulting in them falling backwards and hitting the coffee table, fracturing her rib.
Patient Sequence No: 1, Text Type: N, H10
[93416758]
The lift was traveling towards the bottom, there was a program shift causing an interruption in travel and the level safety to engage. Customer was 27 inches off the ground. Her husband attempted to help her off. She slid off the seat and they both fell against the coffee table, resulting in a hairline rib fracture
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003124453-2017-00009 |
| MDR Report Key | 7073142 |
| Report Source | CONSUMER |
| Date Received | 2017-11-30 |
| Date of Report | 2017-11-30 |
| Date of Event | 2017-11-02 |
| Date Mfgr Received | 2017-11-03 |
| Device Manufacturer Date | 2016-09-23 |
| Date Added to Maude | 2017-11-30 |
| 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 | MS. TRACY BERO |
| Manufacturer Street | 7001 LAKE ELLENOR DRIVE |
| Manufacturer City | ORLANDO FL 328095792 |
| Manufacturer Country | US |
| Manufacturer Postal | 328095792 |
| Manufacturer Phone | 4076500216 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACORN 180 LH |
| Generic Name | POWER STAIRWAY CHAIRLIFT |
| Product Code | PCD |
| Date Received | 2017-11-30 |
| 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 328095792 US 328095792 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2017-11-30 |