MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-05-09 for PAL PAL 120 manufactured by Concord Elevator Ltd..
[74740101]
This incident took place in (b)(6) however these units were sold throughout the united states. Savaria has sent a technical announcement advising all known companies of this hazard and recommended immediate action to correct. We have included a suggested method to correct this fault and given contact information if they have any questions. We have also asked that they pass this information along to anyone who may come in contact with equipment of the design.
Patient Sequence No: 1, Text Type: N, H10
[74740102]
While in operation travelling in the up direction from the lower landing the front tower cover hooked on the car sling pushing the panel upward. The middle of 3 panels came detached and slid down the front of the tower. The user was pushing the up direction button with his hand on the grabrail. The tower cover came down onto the handle and severed his finger.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005753836-2016-00001 |
| MDR Report Key | 6554075 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-05-09 |
| Date of Report | 2016-02-26 |
| Date of Event | 2016-01-07 |
| Report Date | 2016-01-19 |
| Date Reported to Mfgr | 2016-01-19 |
| Date Mfgr Received | 2016-01-19 |
| Device Manufacturer Date | 2004-05-27 |
| 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 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PAL |
| Generic Name | VERTICAL PLATFORM LIFT |
| Product Code | PCE |
| Date Received | 2017-05-09 |
| Model Number | PAL 120 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONCORD ELEVATOR LTD. |
| Manufacturer Address | CA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2017-05-09 |