MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-03-18 for BRUNO ELECTRA RIDE ELITE SRE-2000 manufactured by Bruno Independent Living Aids.
[3319418]
Customer/end user, was riding the stairlift down her stairway. Customer reached down and turned off the unit using the circuit breaker/battery disconnect rocker switch, which made the unit stop 6 steps from the bottom of the stairs. The customer got up from the chair to answer the front door, and fell down the steps, suffering multiple injuries.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2131358-2013-00017 |
MDR Report Key | 3020634 |
Report Source | 04 |
Date Received | 2013-03-18 |
Date of Report | 2013-03-15 |
Date of Event | 2013-01-14 |
Date Mfgr Received | 2013-01-14 |
Device Manufacturer Date | 2007-04-01 |
Date Added to Maude | 2013-03-27 |
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 | OT |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | BRUNO ELECTRA RIDE ELITE |
Generic Name | INCLINED STAIRWAY ELEVATOR |
Product Code | ILK |
Date Received | 2013-03-18 |
Model Number | SRE-2000 |
Operator | LAY USER/PATIENT |
Device Availability | N |
Device Age | DA |
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 | 1. Hospitalization | 2013-03-18 |