MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-01-27 for ACORN 130 RH manufactured by Acorn Stairlifts, Inc..
[66005927]
Root cause of hinge strut becoming loose was gasket inside strut losing integrity, releasing pressure.
Patient Sequence No: 1, Text Type: N, H10
[66005928]
Client was picking up bags off the floor and hinged rail came down and hit her knee. Fractured patella.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 3003124453-2017-00003 |
MDR Report Key | 6283982 |
Report Source | COMPANY REPRESENTATIVE |
Date Received | 2017-01-27 |
Date of Report | 2017-01-27 |
Date of Event | 2016-11-09 |
Date Mfgr Received | 2016-12-29 |
Device Manufacturer Date | 2016-08-16 |
Date Added to Maude | 2017-01-27 |
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 | SERVICE AND TESTING PERSONNEL |
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 | IN |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | ACORN 130 RH |
Generic Name | POWERED STAIRWAY CHAIRLIFT |
Product Code | PCD |
Date Received | 2017-01-27 |
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 32809 US 32809 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Hospitalization | 2017-01-27 |