| TGA Action ID |
RC-2026-RN-00647-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
MEDUMAT Standard2 ventilators
Product codes: WM 28710-01, WM 28710-02, WM 28710-03, WM 28710-04
Sales variants: WM 29300, WM 29500, WM 29350, WM 29550
Serial numbers: 14756, 17247, 17248 and 17249 |
| ARTG Number |
221469 |
| Unique Device Identifier (UDI) |
010405465234805 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Post-market surveillance by the manufacturer identified usage-related incidents in emergency ventilation caused by undetected leakage and disconnections in the breathing circuit (mask, airway device, ventilation hose, measuring circuit, PEEP control tube, pressure measuring tube, Flow Check sensor, CO2 measuring tube, elbow, breathing system filter).
These leaks/disconnections may prevent effective ventilation and expose patients to life-threatening injuries.
Between 2023 and 2026, nine (9) incidents have been reported, including three (3) reports of serious injury. |
| Instructions for Customers/Users |
Customers are to:
- Display the 'Information on undetected leakage during ventilation with MEDUMAT Standard2' notice in relevant operational areas.
- Review and implement the supplement to the instructions for use. Perform pre-use function checks and monitoring for leaks/disconnections and responding appropriately to alarms such as “Airway pressure low”, “Apnea”, “MVe low”, and “Leak on patient side.”
- Ensure that all operators are trained in the recognition of measured values indicating leakage (low/no Vte, low/no MVe, insufficient pressure build-up). |
| Action Commencement Date |
26/08/2026 |
| Responsible Entity |
|
| Contact Information |
0418 108 834 - Roger Buckle, RAPP Australia |