MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2001-12-04 for BRUNO ELECTRA-RIDE II SRE-1550WF * manufactured by Bruno Independent Living Aids.
[16615866]
Customer sat down in the chair of the stairlift installed at their home. The chair pivoted backwards causing pt to be dumped out down the stairway.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2131358-2001-00004 |
| MDR Report Key | 365406 |
| Report Source | 00 |
| Date Received | 2001-12-04 |
| Date of Report | 2001-11-30 |
| Date of Event | 2001-11-09 |
| Date Mfgr Received | 2001-11-12 |
| Device Manufacturer Date | 2001-09-01 |
| Date Added to Maude | 2001-12-14 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | TERRY ANDRUS |
| Manufacturer Street | 1780 EXECUTIVE DRIVE PO BOX 84 |
| Manufacturer City | OCONOMOWOC WI 53066 |
| Manufacturer Country | US |
| Manufacturer Postal | 53066 |
| Manufacturer Phone | 2625674990 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| 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 | 2001-12-04 |
| Returned To Mfg | 2001-11-21 |
| Model Number | SRE-1550WF |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 354527 |
| Manufacturer | BRUNO INDEPENDENT LIVING AIDS |
| Manufacturer Address | 1780 EXECUTIVE DRIVE PO BOX 84 OCONOMOWOC WI 53066 US |
| Baseline Brand Name | BRUNO ELECTRA-RIDE II |
| Baseline Generic Name | INCLINED STAIRWAY ELEVATOR |
| Baseline Model No | SRE-1550WF |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-12-04 |