Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 18161 |
| Brand Name: | Dameca Anaesthesia Machines |
| Model: | IntelliSave AX700 (866205/10623-00), Dameca MRI508 (866203/10651MRI-00), Siesta iWhispa (866202/10651-00), Siesta iTS (866163/10653-00), Siesta Breasy (866204/10652-00) |
| Affected: | All serial numbers |
| Software version: | |
| Recalling Organisation: | Device Technologies New Zealand 47 Arrenway Drive Albany AUCKLAND 0632 |
| Contact Information: | 09 913 2000 |
| Manufacturer: | Dameca A/S |
| Issue: | If the patient is connected to the anaesthesia machine in a volume controlled ventilation mode, and attempts a large spontaneous breath, it is possible for the patient to create a high negative airway pressure, around the same time as a volume controlled breath (mandatory breath).This pressure will be limited by the mechanical Negative Pressure Limiter (NPL) valve. The NPL valve opens if the patient generates a negative pressure of -5 and -7.5 cmH20 (hPa). This opening pressure of the NPL valve is defined at an inspiratory flow rate of 3.5-4.5 L/min. If the patient creates a higher flow rate than 4.5 L/min, the NPL valve will continue to function but due to the resistance of the flow and time taken to reach the patient, the airway pressure may decrease further. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Sponsor Control |
| Date Commenced: | 5/3/2015 |
