MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2006-10-04 for BRUNO ELECTRA-RIDE II SRE-2700 manufactured by Bruno Independent Living Aids.
[3309137]
The customer was either on his way up or down, it is not known which, when the seat tipped over to the side. The customer then fell down approximately 17 stairs, ending up on the floor. It is not known if the customer was wearing the seat belt or not.
Patient Sequence No: 1, Text Type: D, B5
[10492641]
The initial eval was conducted by a (b)(4) dealer. Bruno has concluded that this incident occurred as a result of installation and/or service related issues and was not a product issue. Bruno is in the process of replacing the stairlift. Upon this installation the original stairlift will be returned to bruno for eval.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2131358-2006-00008 |
| MDR Report Key | 2923297 |
| Report Source | 08 |
| Date Received | 2006-10-04 |
| Date of Report | 2006-09-08 |
| Date of Event | 2006-09-01 |
| Date Mfgr Received | 2006-09-08 |
| Device Manufacturer Date | 2005-01-01 |
| Date Added to Maude | 2013-01-23 |
| 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. PO 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 | 2006-10-04 |
| Model Number | SRE-2700 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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. Hospitalization; 2. Other | 2006-10-04 |