FDA Adverse Event
Malfunction
Summary report: N
SAVARIA
MDR report key: 6554074
·
Received May 9, 2017
Report
- Report Number
- 3005753836-2016-00004
- Event Type
- Malfunction
- Date Received
- May 9, 2017
- Date of Event
- July 30, 2015
- Report Date
- July 11, 2016
- Manufacturer
- SAVARIA CONCORD LIFTS INC
- Product Code
- PCD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
THE STAIRLIFT OPERATED PROPERLY STOPPING AT THE BOTTOM LANDING OF THE STAIRCASE. THE USER EXITED THE AREA OF THE LIFT AND THE USERS HUSBAND ATTEMPTED TO RUN THE LIFT BACK UP THE STAIRS. THE LIFT DID NOT OPERATE AND THE OPERATOR NOTICED THE CIRCUIT BREAKER HAD TRIPPED ON THE UNIT. HE ATTEMPTED TO RE SET THE BREAKER AND IT IMMEDIATELY TRIPPED AGAIN. HE ONCE AGAIN RE SET THE BREAKER HOLDING IT IN THE ON (CLOSED) POSITION AND THE UNIT SPARKED AND START TO BURN. THE PERSON EXTINGUISHED THE FLAME WITH NO HARM OR INJURY TO ANY PERSON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 336812 | SAVARIA | SL 1000 | PCD | SAVARIA CONCORD LIFTS INC | SL 1000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |