MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2006-10-19 for BRUNO ELECTRA-RIDE II SRE-1540 manufactured by Bruno Independent Living Aids, Inc..
[21459360]
The customer was riding the stairlift and was at the tip of the stairs; when the seat started to fall backwards. The customer was able to grab the stairway railing and pull himself onto the top landing. Did not seek immediate medical attention.
Patient Sequence No: 1, Text Type: D, B5
[21488276]
As of the date of this submission, replacement parts have been sent to a bruno dealer for installation. However there has been some delay. The dealer that is making the changeout is not the dealer that did the original installation. Once the unit is changed out, it will be sent to bruno for eval.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2131358-2006-00010 |
| MDR Report Key | 2783778 |
| Report Source | 08 |
| Date Received | 2006-10-19 |
| Date of Report | 2006-09-22 |
| Date of Event | 2006-09-22 |
| Date Mfgr Received | 2006-09-22 |
| Device Manufacturer Date | 2002-03-01 |
| Date Added to Maude | 2012-10-22 |
| 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 Street | 1780 EXECUTIVE DR. |
| Manufacturer City | OCONOMOWOC WI 53066 |
| Manufacturer Country | US |
| Manufacturer Postal | 53066 |
| Manufacturer Phone | 2625674990 |
| Manufacturer G1 | BRUNO INDEPENDENT LIVING AIDS, INC. |
| Manufacturer Street | 1780 EXECUTIVE DR. |
| Manufacturer City | OCONOMOWOC WI 53066 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53066 |
| 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 | 2006-10-19 |
| Model Number | SRE-1540 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BRUNO INDEPENDENT LIVING AIDS, INC. |
| Manufacturer Address | 1780 EXECUTIVE DR. OCONOMOWOC WI 53066 US 53066 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-10-19 |