| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00057-1 |
| Product Name/Description |
Servo-n HFOV
System Version: 4.4, 4.5
Item Number: 66 88 600
ARTG 218345
(Getinge Australia Pty Ltd - Ventilator, neonatal/paediatric) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
23/01/2024 |
| Responsible Entity |
|
| Reason/Issue |
Getinge is informing users about a limitation of the intended performance of Servo-n during high frequency oscillatory ventilation (HFOV) when using the Fisher & Paykel neonatal circuit (950N81 or equivalent) and the humidifier FP950.
Getinge received one complaint that HFOV was not performing as expected for patients with certain body weights with regard to pressure amplitude (Pampl) and high frequency tidal volume (VThf).
The investigation indicated that the use of a relatively small endotracheal (ET) tube in relation to body weight and in combination with the Fisher & Paykel neonatal circuit that is used with the FP950 humidifier limits the delivered Pampl and therefore reduces the delivered VThf.
The hazardous situation may include the risk of hypoxia, hypoventilation and consequently delay of treatment.
However, alarms regarding low VThf and low amplitudes will make clinicians aware of the problem and shorten detection time. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
As stated in the IFU (chapter 1.2), customers must:
·Never leave the patient unattended when connected to the ventilator system.
·Ensure adequate external monitoring and blood gas analysis during HFOV.
·Always make sure that a manual resuscitator is readily available.
Getinge will add new information, including a warning, into Servo-n IFU for System Version 4.4 and later software versions. The updated IFU will be distributed to all affected customers.
In the meantime, customers must read and understand the content of the customer letter. They must pay extra attention to ET tube size in relation to body weight when using Fisher & Paykel 12 mm circuit 950N81 with Servo-n HFOV for patients 1-3 kg.
It is recommended to use the Getinge 15 mm HFOV circuit and Fisher & Paykel’s MR850 humidifier for infants (1-3 kg) in case a relatively small ET tube size is used in relation to body weight as well as for infants >3 kg.
This action has been closed out on 15/4/2024. |
| Contact Information |
1800 438 464 - Getinge Australia Pty Ltd |