| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00154-1 |
| Product Name/Description |
Drager V Series Ventilator with the Optional PS500 Installed
Affected Models: Infinity V500; Evita V300; and Babylog VN500
All Serial Numbers affected
ARTG Numbers: 158739, 170141 and 92177 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
10/02/2016 |
| Responsible Entity |
|
| Reason/Issue |
The battery capacity of the optional PS500 power supply unit for the Evita Infinity V500, Evita Infinity V300 and the Babylog VN500 rapidly and unexpectedly reduces despite using the most recent power supply firmware (FW1 .50) which was released in November 2015 .
This resulted in batteries prematurely discharging, even though an adequate battery charge status was displayed. The "Battery discharged" alarm was not in all cases triggered five minutes prior to battery discharge, as specified. When the batteries were completely discharged, the devices triggered the existing power failure alarm correctly.
The reported issue may cause unexpected loss of automatic ventilation functionality which could lead to serious injuries to the patient. So far no injuries have been reported. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The sponsor is cancelling the distribution of the updated power supply firmware (FW1.50) and rolling back devices on which this firmware version is already installed to FW1.49. As a preventive measure, Dräger will replace the batteries of all PS500 customers every 6 months until a permanent technical solution is available. Dräger is also advising users NOT to use the device for patient transport unless absolutely necessary and NOT to rely on the battery status indicator. |
| Contact Information |
03 9244 7248 - Draeger Medical Australia |