MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-01-11 for ACORN 130 RH manufactured by Acorn Stairlifts, Inc.
[64557426]
Root cause could not be determined since client's legal representative refused to allow an investigation. Physical evidence review from photos suggests most likely underlying cause to be an impact to the seat with considerable force, not normal use within specification. Investigation will be conducted once legal representative releases the seat to acorn.
Patient Sequence No: 1, Text Type: N, H10
[64557427]
Grandson of user called to report that seat had snapped and user had fallen.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003124453-2017-00001 |
| MDR Report Key | 6244093 |
| Report Source | CONSUMER |
| Date Received | 2017-01-11 |
| Date of Report | 2017-01-11 |
| Date of Event | 2016-12-12 |
| Date Mfgr Received | 2016-12-12 |
| Device Manufacturer Date | 2016-11-02 |
| Date Added to Maude | 2017-01-11 |
| 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 130 RH |
| Generic Name | POWERED STAIRWAY CHAIRLIFT |
| Product Code | PCD |
| Date Received | 2017-01-11 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2017-01-11 |