MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2008-01-03 for BRUNO ELECTRA-RIDE II SRE-1550 manufactured by Bruno Independent Living Aids.
[2016904]
Customer was riding the sre-1550 inclined stairlift on his stairway when the seat assembly pivot bolt became loose, this caused the seat assembly to pivot to one side. The customer fell out of the seat and down 10 stairs. The customer may or may not have sought medical attention due to this incident.
Patient Sequence No: 1, Text Type: D, B5
[9155834]
As of the submission of this report, the authorized bruno dealer that had done the installation, had gone to the customer's residence and repaired the unit to its original condition.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2131358-2007-00012 |
| MDR Report Key | 2136547 |
| Report Source | 08 |
| Date Received | 2008-01-03 |
| Date of Report | 2007-12-05 |
| Date of Event | 2007-12-05 |
| Date Mfgr Received | 2007-12-05 |
| Device Manufacturer Date | 2007-08-01 |
| Date Added to Maude | 2011-06-30 |
| 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 | RP |
| 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 | 2008-01-03 |
| Model Number | SRE-1550 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2008-01-03 |