MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2006-10-12 for BRUNO ELECTRA-RIDE II SRE-2000 manufactured by Bruno Independent Living Aids.
[15631851]
User was riding stairlift, when the seat broke in such a way that the user fell off the stairlift seat on to the floor. The user received a cut on his leg. Bruno does not know if the user received medical attention, or not.
Patient Sequence No: 1, Text Type: D, B5
[15989621]
Conclusion: reviewing the returned unit and the model sre-2000 customer complaint records - i feel that this is an isolated failure caused by joint failure whose root cause is poor weld penetration, as the operator followed the part contour.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2131358-2006-00009 |
| MDR Report Key | 1349503 |
| Report Source | 08 |
| Date Received | 2006-10-12 |
| Date of Report | 2006-10-01 |
| Date of Event | 2006-09-11 |
| Date Mfgr Received | 2006-09-11 |
| Device Manufacturer Date | 2002-11-01 |
| Date Added to Maude | 2009-07-06 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | TERRY ANDRUS |
| Manufacturer Street | 1780 EXECUTIVE DR. P O BOX 84 |
| Manufacturer City | OCONOMOWOC WI 53066 |
| Manufacturer Country | US |
| Manufacturer Postal | 53066 |
| Manufacturer Phone | 2625674990 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BRUNO ELECTRA-RIDE II |
| Generic Name | INCLINED STAIRWAY ELEVATOR |
| Product Code | ILK |
| Date Received | 2006-10-12 |
| Model Number | SRE-2000 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BRUNO INDEPENDENT LIVING AIDS |
| Manufacturer Address | OCONOMOWOC WI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-10-12 |