MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2017-05-09 for SAVARIA OMEGA manufactured by Savaria Concord Lifts Inc.
[74740493]
Total units effected in the united states = (b)(4). As of reporting april 1 2016 - (b)(4) 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: 02/18/2014. Follow up for work completion date: april 2014, july 2014 , december 2014, february 2015, april 2015 - dealers requesting new kits were sent: august 2015, december 2015, february 2016, march 2016.
Patient Sequence No: 1, Text Type: N, H10
[74740494]
During normal operation, the lift while carrying a passenger and wheelchair in the down direction came unfastened from the upper lifting trolley and lifting cable. The carriage and platform now released from the cable system slid down the length of stairs being guided by the lower trolley that remained connected. The platform hit the bottom landing causing the rider to be thrown forward hitting their head against the wall. It was found that the 5 bolts that were holding the carriage to the upper trolley worked loose and eventually failed releasing the platform.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005753836-2016-00003 |
| MDR Report Key | 6554078 |
| Report Source | FOREIGN |
| Date Received | 2017-05-09 |
| Date of Report | 2016-04-04 |
| Date of Event | 2014-02-07 |
| Report Date | 2014-02-07 |
| Date Reported to Mfgr | 2014-02-07 |
| Device Manufacturer Date | 2013-01-15 |
| 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 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAVARIA |
| Generic Name | INCLINE PLATFORM LIFT |
| Product Code | PCE |
| Date Received | 2017-05-09 |
| Model Number | OMEGA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | R |
| 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. Hospitalization | 2017-05-09 |