MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2001-05-08 for BRUNO ELECTRA-RIDE SRE-1500 * manufactured by Bruno Independent Living Aids, Inc..
[17481561]
The original unit was installed in feb. 1995. It was removed and reinstalled in the customer's new house in jan. 2000. The customer was riding the unit down the stairway and had moved about a third of the way down, when the main drive gear walked itself off the rail gear, causing the stairlift to free-wheel the remaining distance to the bottom of the stairway. When the stairlift stopped suddenly at the bottom of the stairway, the customer was not wearing the seatbelt provided at the time of the incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2131358-2001-00001 |
| MDR Report Key | 332440 |
| Report Source | 04 |
| Date Received | 2001-05-08 |
| Date of Report | 2001-05-02 |
| Date of Event | 2001-04-27 |
| Date Mfgr Received | 2001-05-02 |
| Device Manufacturer Date | 1996-03-01 |
| Date Added to Maude | 2001-05-15 |
| 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 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | TERRY ANDRUS |
| Manufacturer Street | 1780 EXECUTIVE DRIVE P.O. 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 | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BRUNO ELECTRA-RIDE |
| Generic Name | INCLINED STARIWAY ELEVATOR |
| Product Code | ILK |
| Date Received | 2001-05-08 |
| Model Number | SRE-1500 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 321796 |
| Manufacturer | BRUNO INDEPENDENT LIVING AIDS, INC. |
| Manufacturer Address | 1780 EXECUTIVE DR. P.O. BOX 84 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 | 2001-05-08 |