MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-09 for STAIRFRIEND CSL 3000 manufactured by Savaria Concord Lifts Inc.
[74909594]
Total units effected in the united states 119. As of reporting april 1 2016 - 44 units remain not corrected. The following dates are contacts with dealers by phone and/or email to enforce the requirement to correct the welded part. Initial parts order and shipment date. February 25th 2015, february 26th 2015 ,february 27th 2015. Follow up for work completion date. On may 2015 - insure receipt and understanding of correction august 2015 - follow up non completed units. On september - 2015 follow up non completed units. December - 2015 follow up non completed units. Sales department following up on individual basis.
Patient Sequence No: 1, Text Type: N, H10
[74909595]
During operation it was found that some of the seat post welds were not properly done and the weld would crack causing the seat to tilt. Once tilted the seat is unable to swivel and if not addressed the seat post weld would continue to crack eventually corning completely separated there is the potential for the user to fall possibly causing injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005753836-2016-00002 |
| MDR Report Key | 6554099 |
| Date Received | 2017-05-09 |
| Date of Report | 2016-03-28 |
| Date of Event | 2015-02-24 |
| Report Date | 2015-02-23 |
| Date Reported to Mfgr | 2015-02-23 |
| Date Mfgr Received | 2015-02-24 |
| Device Manufacturer Date | 2014-03-01 |
| 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 | STAIRFRIEND |
| Generic Name | CURVED STIAR CHAIR LIFT |
| Product Code | PCD |
| Date Received | 2017-05-09 |
| Model Number | CSL 3000 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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 | 1. Required No Informationntervention | 2017-05-09 |