| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00147-1 |
| Product Name/Description |
LUCAS 2 Chest Compression System
Item Number : 3302430-145
Multiple Serial Numbers
Manufactured between September 2014 and April 2015
ARTG Number: 121182
(Stryker Australia Pty Ltd - Resuscitator, cardiac, electrically-powered) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
21/02/2018 |
| Responsible Entity |
|
| Reason/Issue |
Stryker has become aware of a potential reliability issue where the LUCAS device may not respond to the push of certain buttons due to potential damage of an internal cable. The User Control Panel cable can be damaged by rubbing against an adjacent cable connector.
If the malfunction were to occur, it may cause the device to exhibit one of the following:
·The device does not change from one ACTIVE mode to the other;
·The device does not begin compressions; or
·The device does not temporarily stop and lock in the Start Position when the PAUSE button is pressed. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
A Stryker Technical Operations representative will be in contact with users upon receipt of the form supplied with the Customer Letter to arrange for replacement of an internal cable.
Users are advised to refer to Sections 3.8 and 5.4 of the IFU which states that if there are interruptions, if the compressions are not sufficient, or something unusual occurs during operation: push ON/OFF for 1 second to stop LUCAS and remove the device from the patient. Immediately start manual chest compressions.
This action has been closed out on 19/11/2018 |
| Contact Information |
02 9467 1175 - Customer Service Support |