MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 1998-09-10 for BRUNO ELECTRA-RIDE SRE-1500 * manufactured by Bruno Independent Living Aids.
[100388]
Customer claims he rode the stairflift to the top of the stairs. As pt reached the top, the main drive gear fell off of the unit. This caused the stairlift to free fall, stoping at the bottom of the stairs, throwing pt into the drywall.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2131358-1998-00001 |
| MDR Report Key | 187008 |
| Report Source | 04 |
| Date Received | 1998-09-10 |
| Date of Report | 1998-08-18 |
| Date of Event | 1998-07-27 |
| Date Mfgr Received | 1998-08-18 |
| Device Manufacturer Date | 1996-01-01 |
| Date Added to Maude | 1998-09-15 |
| 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 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BRUNO ELECTRA-RIDE |
| Generic Name | INCLINED STAIRWAY ELEVATOR |
| Product Code | ILK |
| Date Received | 1998-09-10 |
| Model Number | SRE-1500 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 181776 |
| Manufacturer | BRUNO INDEPENDENT LIVING AIDS |
| Manufacturer Address | 1780 EXECUTIVE DR. OCONOMOWOC WI 53066 US |
| Baseline Brand Name | ELECTRA-RIDE STAIRWAY ELEVATOR |
| Baseline Generic Name | INCLINED STAIRWAY ELEVATOR |
| Baseline Model No | SRE-1500 |
| Baseline Catalog No | NA |
| Baseline ID | SRE-1500 |
| Baseline Device Family | ELECTRA-RIDE STAIRWAY ELEVATORS |
| Baseline Shelf Life Contained | A |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K921648 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-09-10 |