MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-11-14 for 130 ACORN T700 RH manufactured by Acorn Stairlifts, Inc..
[127203604]
The customer was not able to recall the exact date of the incident, only remembering that the incident occurred in (b)(6) 2018. The incident was not reported to acorn stairlifts, inc. (acorn) until october 15, 2018. The customer kept the hinge rail in the down position while the stairlift was not in use, instead of following the manufacturer's instructions to raise the hinge. The customer claims they were never shown how to operate the manual hinge on the rail; however, acorn has two work reports documenting the customer's acknowledgement that "... The hinge must be placed in the upright position when the stairlift is not in use". At the time of installation, the customer was provided a user manual. The bottom of page 9 of the user manual discusses the manual hinge, and page 4 of the manual discusses potential trip hazard, including the hinge. [(b)(4)].
Patient Sequence No: 1, Text Type: N, H10
[127203605]
In (b)(6) 2018 the customer was walking on the first floor of her home in the vicinity of the stairlift. The customer has a hinged rail installed to prevent the rail from obstructing the walkway; however, the customer had the hinged portion of the rail in the down position when the stairlift was not in use, instead of following the manufacturer's instructions to raise the hinge. The customer tripped over the hinge portion of the rail breaking her hip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003124453-2018-00003 |
| MDR Report Key | 8071539 |
| Report Source | CONSUMER |
| Date Received | 2018-11-14 |
| Date of Report | 2018-11-14 |
| Date Mfgr Received | 2018-10-15 |
| Device Manufacturer Date | 2017-11-13 |
| Date Added to Maude | 2018-11-14 |
| 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 | MRS. 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 | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 130 ACORN T700 RH |
| Generic Name | POWER STAIRWAY CHAIRLIFT |
| Product Code | PCD |
| Date Received | 2018-11-14 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-11-14 |