| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00176-1 |
| Product Name/Description |
Drager V Series Ventilator with the Optional PS500 External Power Supply Unit 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 |
6/02/2017 |
| Responsible Entity |
|
| Reason/Issue |
Dräger became aware that the battery capacity of the optional PS500 power supply unit was unexpectedly reduced. 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.
Further to the recall for product correction in Feb 2016 (TGA Ref.: RC-2016-RN-00154-1), Dräger has now developed device modifications to rectify the issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The device modifications include the following:
- Installation of a new software 2.50 with improved battery charge management
- Improved charge management for external batteries
- Option of performing a battery check to determine the battery's current runtime
- Option of displaying the remaining battery capacity in minutes
- Installation of an additional internal backup battery
- Replacement of the power supply unit to support both the external battery and an additional internal battery
- Replacement of the existing external batteries.
The installation of a backup battery will ensure that the internal battery will continue to supply power should the external battery fail. Users are advised to continue to observe the information in the Feb 2016 letter until the devices have been updated with the improved system.
This action has been closed out on 11/10/2018 |
| Contact Information |
03 9244 7248 - Draeger Medical Australia |