| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00782-1 |
| Product Name/Description |
SERVO-i/s ventilator systems with software version 8.00.00
Affected devices: SW Service Release v8.00.00 SERVO-I - 68 85 247 and SW Service Release v8.00.00 ERVO-s – 68 85 259
ARTG Number: 162468 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
15/06/2016 |
| Responsible Entity |
|
| Reason/Issue |
Maquet have become aware of improper behaviour introduced in SERVO-i and SERVO-s ventilator system SW version 8.00.00.
The improper behaviour in System SW version 8.00.00 appears as follows:
· If ventilation is started with Infant factory default settings, the following settings will apply:
Pressure Control mode; and
10 cmH2O PC above PEEP.
· The system will deliver a pressure of 20 cmH2O above PEEP as long as the factory default setting 10 cmH2O is used unchanged.
For the infant patient category a delivered pressure of 20cmH2O above PEEP instead of preset 10cmH2O above PEEP may cause serious injury. The error was discovered at the production site and there are no reported injuries. The issue would be apparent in the pressure curve and peak pressure displayed on the screen. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Maquet is advising users to change the default settings of pressure above PEEP in the infant patient category. The ventilator will only deliver a pressure of 20 cmH2O above PEEP if the default start-up configuration of the pressure has not been changed. A new system software version 8.00.01 is available that will eliminate this behaviour. Maquet has initiated an immediate update of all affected SERVO-i and SERVO-s ventilator systems. This action has been closed-out on 27/01/2017. |
| Contact Information |
1800 605 824 - Director of Post-market, Maquet Australia |