MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-09 for SAVARIA SL 1000 manufactured by Savaria Concord Lifts Inc.
[74905955]
Patient Sequence No: 1, Text Type: N, H10
[74905956]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005753836-2016-00004 |
| MDR Report Key | 6554074 |
| Date Received | 2017-05-09 |
| Date of Report | 2016-07-11 |
| Date of Event | 2015-07-30 |
| Date Added to Maude | 2017-05-09 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. WILLIAM RICHARDSON |
| Manufacturer Street | 2 WALKER DRIVE |
| Manufacturer City | BRAMPTON, ONTARIO L6T5E1 |
| Manufacturer Country | CA |
| Manufacturer Postal | L6T5E1 |
| Manufacturer Phone | 7995555 |
| Manufacturer G1 | SAVARIA CONCORD LIFTS INC |
| Manufacturer Street | 2 WALKER DRIVE |
| Manufacturer City | BRAMPTON, ONTARIO L6T5E1 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | L6T5E1 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SAVARIA |
| Generic Name | SL 1000 |
| Product Code | PCD |
| Date Received | 2017-05-09 |
| Returned To Mfg | 2015-01-12 |
| Model Number | SL 1000 |
| Operator | PATIENT FAMILY MEMBER OR FRIEND |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SAVARIA CONCORD LIFTS INC |
| Manufacturer Address | 2 WALKER DRIVE BRAMPTON, ONTARIO L6T5E1 CA L6T5E1 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-09 |