| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2021-RN-02430-1 |
| Product Name/Description |
Bellavista 1000 and 1000E Ventilators
Material numbers: 301.100.000 & 301.100.100
Multiple serial numbers
ARTG: 332363 (Vyaire Medical Pty Ltd - Ventilator, adult) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
24/12/2021 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has received reports that on Bellavista ventilators with generation 6 (G6) hardware, ventilation may cease during clinical use, and ventilation monitoring waveforms and parameters may become frozen (not updated). The ventilator generates a continuous audible and visual high priority alarm for “technical failure 305”. Ventilation is suspended until the unit is rebooted or replaced.
For the failure condition to occur, the following conditions must exist:
1. Software version 6.0.1600.0 (released 12 February 2021) or higher installed AND;
2. Software option “Data Communication” be installed AND;
3. Data communication port configured to “HL7” (only possible when condition 2 is fulfilled). |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are advised to disable the HL7 protocol where enabled by following the instructions in the Customer Letter (supplied to impacted facilities by Vyaire).
Note: some devices may not have the function enabled.
If the failure condition occurs, take the device out of use and contact Vyaire Medical.
UPDATE March 2022: the software update to correct this issue is now available. Vyaire reps will be in contact with affected customers to arrange for the update to be installed. |
| Contact Information |
0414 108 224 - Beau Ravan-Geekie |