FDA Adverse Event
Malfunction
Summary report: N
BRUNO ELECTRA-RIDE II
MDR report key: 2783778
·
Received October 19, 2006
Report
- Report Number
- 2131358-2006-00010
- Event Type
- Malfunction
- Date Received
- October 19, 2006
- Date of Event
- September 22, 2006
- Report Date
- September 22, 2006
- Manufacturer
- BRUNO INDEPENDENT LIVING AIDS, INC.
- Product Code
- ILK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AS OF THE DATE OF THIS SUBMISSION, REPLACEMENT PARTS HAVE BEEN SENT TO A BRUNO DEALER FOR INSTALLATION. HOWEVER THERE HAS BEEN SOME DELAY. THE DEALER THAT IS MAKING THE CHANGEOUT IS NOT THE DEALER THAT DID THE ORIGINAL INSTALLATION. ONCE THE UNIT IS CHANGED OUT, IT WILL BE SENT TO BRUNO FOR EVAL.
Description of Event or Problem · 1
THE CUSTOMER WAS RIDING THE STAIRLIFT AND WAS AT THE TIP OF THE STAIRS; WHEN THE SEAT STARTED TO FALL BACKWARDS. THE CUSTOMER WAS ABLE TO GRAB THE STAIRWAY RAILING AND PULL HIMSELF ONTO THE TOP LANDING. DID NOT SEEK IMMEDIATE MEDICAL ATTENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BRUNO ELECTRA-RIDE II | INCLINED STAIRWAY ELEVATOR | ILK | BRUNO INDEPENDENT LIVING AIDS, INC. | SRE-1540 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |